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 2011-02-10 for HYPERFORM OCCLUSION BALLOON SYSTEM 104-4470 manufactured by Ev3 Neurovascular.
[9162085]
The catheter has been evaluated. A larger amount of blood was found inside the catheter's lumen which likely inhibited balloon visualization. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[15534623]
Embolization treatment of a basilar top aneurysm. It was reported after deployed two coils; the balloon was inflated and could not be visualized. A digital subtraction angiography (dsa) was performed and showed there was no flow in the basilar. The balloon was deflated and removed from the patient. It was reported the patient expired post coiling procedure and the cause of death was unknown.
Patient Sequence No: 1, Text Type: D, B5
[15847502]
The device involved in this event has not been returned for evaluation. Reference (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2011-00032 |
| MDR Report Key | 1984150 |
| Report Source | 04,05,06 |
| Date Received | 2011-02-10 |
| Date of Report | 2011-01-12 |
| Date of Event | 2010-10-10 |
| Date Mfgr Received | 2011-01-12 |
| Device Manufacturer Date | 2010-10-18 |
| Date Added to Maude | 2011-02-10 |
| 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 CATHETER |
| Product Code | MZQ |
| Date Received | 2011-02-10 |
| Returned To Mfg | 2011-02-21 |
| Model Number | 104-4470 |
| Lot Number | 8538842 |
| Device Expiration Date | 2013-03-01 |
| 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. Death | 2011-02-10 |