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 2012-02-29 for HYPERFORM OCCLUSION BALLOON SYSTEM 104-4770 manufactured by Ev3 Neurovascular.
[2476690]
It was reported the balloon could not stayed inflate during preparation. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[9654733]
The balloon catheter has been evaluated and found ruptured at the distal marker band. This likely prevented the balloon from maintain inflation. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2012-00085 |
| MDR Report Key | 2472483 |
| Report Source | 04,05,06 |
| Date Received | 2012-02-29 |
| Date of Report | 2012-02-07 |
| Date of Event | 2012-02-06 |
| Date Mfgr Received | 2012-02-07 |
| Device Manufacturer Date | 2010-10-14 |
| Date Added to Maude | 2012-08-24 |
| 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 | 9496901335 |
| 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 | 2012-02-29 |
| Returned To Mfg | 2012-02-17 |
| Model Number | 104-4770 |
| Lot Number | 9329055 |
| Device Expiration Date | 2012-10-01 |
| 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 | 2012-02-29 |