FDA Adverse Event
Malfunction
Summary report: N
TYSHAK DILATATION CATHETER
MDR report key: 288034
·
Received July 27, 2000
Report
- Report Number
- 1318694-2000-00002
- Event Type
- Malfunction
- Date Received
- July 27, 2000
- Date of Event
- August 24, 1998
- Report Date
- July 27, 2000
- Manufacturer
- NUMED, INC.
- Product Code
- LIT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE BALLOON BURST AT 8ATMS DURING AN UNSPECIFIED PROCEDURE. ITS RATED BURST PRESSURE IS 5ATMS. NO PT INJURY WAS REPORTED. NUMED CONTACTED THE DISTRIBUTOR WHICH PROVIDED THE INITIAL REPORT, BUT THE CO COULD NOT OBTAIN ADD'L INFO REGARDING THIS MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TYSHAK DILATATION CATHETER | PTA CATHETER | LIT | NUMED, INC. | 102 | T-1205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |