MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-09-29 for HYPERFORM OCCLUSION BALLOON SYSTEM 104-4470 manufactured by Ev3 Neurovascular.
[2460069]
It was reported that the guidewire (provided with the balloon system) broke inside the balloon catheter during procedure. The entire system was removed from the tp and the procedure continued with a new system. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[9562298]
The guidewire was returned with approx 10 cm of the distal tip missing. Analysis of the break point showed the failure of the core wire occurred due to fatigue torsional overload. The balloon catheter was also returned and found ruptured. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2011-00276 |
| MDR Report Key | 2371416 |
| Report Source | 04 |
| Date Received | 2011-09-29 |
| Date of Report | 2011-08-30 |
| Date of Event | 2011-08-25 |
| Date Mfgr Received | 2011-08-30 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2012-03-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIM SALCEDA |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9498373700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYPERFORM OCCLUSION BALLOON SYSTEM |
| Generic Name | OCCLUSION BALLOON, NUF |
| Product Code | NUF |
| Date Received | 2011-09-29 |
| Returned To Mfg | 2011-09-09 |
| Model Number | 104-4470 |
| Lot Number | 9449519 |
| Device Expiration Date | 2014-04-01 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EV3 NEUROVASCULAR |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-29 |