MAUDE report
MAUDE report 3563: HARTZLER MICRO II FIXED WIRE BALLOON CATHETER
Injury · received Jul 31, 1992 · ADVANCED CARDIOVASCULAR SYSTEMS, INC.
Key facts
| MDR report key | 3563 |
|---|---|
| Report number | 3563 |
| Event type | Injury |
| Brand name | HARTZLER MICRO II FIXED WIRE BALLOON CATHETER |
| Catalog number | 11072-104 |
| Manufacturer | ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
| Product code | GBA |
| Device class | Class I |
| PMA or 510(k) number | Device Exempt |
| Date received by FDA | Jul 31, 1992 |
| Report date | Feb 3, 1992 |
| Report source | Maude |
At a glance
- None Device problems coded
- 100–999 MAUDE reports for this product code
- 1–9 MAUDE reports for this brand
- None Death reports for this brand
- 1–9 Injury reports for this brand
- Yes Adverse event flagged
- No Product problem flagged
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE medical device reports
MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.
Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date: