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 2011-11-01 for HYPERGLIDE OCCLUSION BALLOON SYSTEM 104-4112 manufactured by Ev3 Neurovascular.
[17880897]
It was reported the catheter ruptured proximally to the balloon during procedure. Prior to use, the balloon was prep and confirmed work as intended. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[18017000]
The balloon catheter has been evaluated and confirmed the catheter ruptured at approximately 9. 7 cm from the distal tip of the catheter.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2011-00360 |
| MDR Report Key | 2380736 |
| Report Source | 04,05,06 |
| Date Received | 2011-11-01 |
| Date of Report | 2011-10-11 |
| Date of Event | 2011-09-20 |
| Date Mfgr Received | 2011-10-03 |
| Device Manufacturer Date | 2011-05-23 |
| 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 | HYPERGLIDE OCCLUSION BALLOON SYSTEM |
| Generic Name | OCCLUSION BALLOON CATHETER |
| Product Code | NUF |
| Date Received | 2011-11-01 |
| Model Number | 104-4112 |
| Lot Number | 9391000 |
| Device Expiration Date | 2013-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-11-01 |