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 2011-12-21 for HYPERFORM OCCLUSION BALLOON SYSTEM 104-4470 manufactured by Ev3 Neurovascular.
[2501643]
It was reported the balloon could not be visualized during procedure. The physician withdrew the catheter from the patient and blood was found inside the catheter's lumen. At the same time, the aneurysm ruptured and the physician implanted 5 coils to stop the bleed. The patient was reported expired the next day and physician does not think that the balloon was the cause of the event.
Patient Sequence No: 1, Text Type: D, B5
[9561044]
The device involved in this event will not be returned for evaluation as it was discarded. Based on the description of the event, the blood that was found inside the catheter's lumen likely inhibited balloon visualization. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2011-00429 |
| MDR Report Key | 2383950 |
| Report Source | 04,05,06 |
| Date Received | 2011-12-21 |
| Date of Report | 2011-11-21 |
| Date of Event | 2011-11-16 |
| Date Mfgr Received | 2011-11-21 |
| Device Manufacturer Date | 2009-11-19 |
| Date Added to Maude | 2011-12-21 |
| 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 | 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 | 2011-12-21 |
| Model Number | 104-4470 |
| Lot Number | 7952783 |
| Device Expiration Date | 2012-09-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 1. Death | 2011-12-21 |