FDA Adverse Event
Malfunction
Summary report: N
TYSHAK II
MDR report key: 5078138
·
Received September 11, 2015
Report
- Report Number
- 1318694-2015-00006
- Event Type
- Malfunction
- Date Received
- September 11, 2015
- Date of Event
- June 25, 2015
- Report Date
- September 11, 2015
- Manufacturer
- NUMED, INC.
- Product Code
- DQY
- PMA / PMN Number
- K003052
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CATHETER WAS RETURNED AND THE LONGITUDINAL BALLOON BURST WAS CONFIRMED. A COMPARATIVE CATHETER OF THE SAME BALLOON MODEL AND SIZE WAS PULLED AND TESTED FOR RATED BURST PRESSURE. THE LABELED RATED BURST PRESSURE IS 1.5 ATM. THE COMPARATIVE CATHETER DID NOT BURST UNTIL 2.0 ATM, AND IT WAS A LONGITUDINAL BURST. THE PHYSICIAN REPORTED THAT THE BALLOON BURST BEFORE BEING FULLY INFLATED BUT DID NOT PROVIDE THE PRESSURE THAT THE BALLOON WAS TAKEN TO. LONGITUDINAL BURSTS ARE SEEN WHEN THE BALLOONS ARE OVER PRESSURIZED.
Description of Event or Problem · 1
"BALLOON GOT RUPTURES BEFORE BEING FULLY INFLATED", AS PER THE INCIDENT REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601369 | TYSHAK II | DQY | NUMED, INC. | 105 | TT-10689 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR |