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 2012-12-19 for HYPERFORM OCCLUSION BALLOON SYSTEM 104-4470 manufactured by Ev3 Neurovascular.
[3100415]
Treatment of a middle cerebral artery (mca) aneurysm. During the procedure, the physician implanted a target 360 soft 5x10 (from stryker) first and then an orbit galaxy complex 4x10 and 3. 5x9 (from j+j). Upon implanting the third coil, it came out of the neck of the aneurysm and a hyperform balloon was used to push and place the coil back into the aneurysm. At this time, the physician noticed that the aneurysm had ruptured and he used other coils to complete the procedure. No other injury was reported with the patient as a result of the procedure.
Patient Sequence No: 1, Text Type: D, B5
[10290118]
The device involved in the event has not been returned for evaluation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[21895352]
The balloon has been returned and evaluated. A leak was found at 1. 3mm from the distal tip. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2012-00748 |
| MDR Report Key | 2879609 |
| Report Source | 04,05,06 |
| Date Received | 2012-12-19 |
| Date of Report | 2012-12-03 |
| Date of Event | 2012-11-30 |
| Date Mfgr Received | 2012-12-03 |
| Device Manufacturer Date | 2012-06-27 |
| Date Added to Maude | 2012-12-19 |
| 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 | MR. HENRY TO |
| 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 CATHETER |
| Product Code | NUF |
| Date Received | 2012-12-19 |
| Returned To Mfg | 2012-12-20 |
| Model Number | 104-4470 |
| Lot Number | 9609309 |
| Device Expiration Date | 2015-04-25 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| 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 | 1. Deathisabilit | 2012-12-19 |