MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2012-03-14 for HYPERFORM OCCLUSION BALLOON SYSTEM 104-4470 manufactured by Ev3 Neurovascular.
[2548154]
It was reported that after the guidewire (included with the system) was inserted, a kink was observed at the distal end of the system. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[9730416]
The device has been evaluated. The evaluation showed that the guidewire broke into two segments (due to torsion overload) inside the catheter lumen and one of the segments punctured the catheter lumen at 1. 5 cm from the distal tip. Catheter lumen. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2012-00133 |
| MDR Report Key | 2491414 |
| Report Source | 04,05,06 |
| Date Received | 2012-03-14 |
| Date of Report | 2012-02-15 |
| Date of Event | 2012-02-10 |
| Date Mfgr Received | 2012-02-15 |
| Device Manufacturer Date | 2011-12-19 |
| Date Added to Maude | 2012-08-29 |
| 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 | HENRY TO |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9498601335 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYPERFORM OCCLUSION BALLOON SYSTEM |
| Generic Name | OCCLUSION BALLOON CATHETER |
| Product Code | NUF |
| Date Received | 2012-03-14 |
| Returned To Mfg | 2012-02-21 |
| Model Number | 104-4470 |
| Lot Number | 9528400 |
| Device Expiration Date | 2014-10-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2012-03-14 |