FDA Adverse Event
Injury
Summary report: N
TYSHAK DILATATION CATHETER
MDR report key: 287430
·
Received July 27, 2000
Report
- Report Number
- 1318694-2000-00001
- Event Type
- Injury
- Date Received
- July 27, 2000
- Date of Event
- August 31, 1998
- Report Date
- July 27, 2000
- Manufacturer
- NUMED, INC.
- Product Code
- LIT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PERCUTANEOUS CORONARY ANGIOPLASTY BALLOON BURST AT UN UNSPECIFIED PRESSURE DURING AN UNSPECIFIED PROCEDURE. THE DR EXPERIENCED DIFFICULTY IN REMOVING THE CATHETER, WHICH WAS NOT DESCRIBED. NUMED CONTACTED THE DISTRIBUTOR WHO REPORTED THE ADVERSE EVENT. THE CO WAS NOT ABLE TO OBTAIN ANY ADDITIONAL INFO ABOUT THE ADVERSE EVENT, INCLUDING ANY INFO ABOUT THE OUTCOME OF THE PT'S CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TYSHAK DILATATION CATHETER | PTA CATHETER | LIT | NUMED, INC. | 102 | T-1117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |