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 2012-02-09 for HYPERGLIDE OCCLUSION BALLOON SYSTEM 104-4112 manufactured by Ev3 Neurovascular.
[20794215]
It was reported the balloon could not be visualized during contrast injection (50:50 ratio). The physician decided to used 90% concentration contrast media to inflate the balloon and it could not be deflated. The inflated balloon was successfully removed from the patient. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[20965897]
The balloon catheter has been evaluated and a large amount of blood was found in the balloon lumen. Based upon the findings, the large amount of blood found in the balloon assembly was the likely cause of the non-deflation. The instruction for use warns "inadvertent proximal guidewire movement can cause blood to enter the balloon lumen which may inhibit balloon deflation. "(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2012-00046 |
| MDR Report Key | 2445008 |
| Report Source | 04,05,06 |
| Date Received | 2012-02-09 |
| Date of Report | 2012-01-11 |
| Date of Event | 2012-01-11 |
| Date Mfgr Received | 2012-01-11 |
| Device Manufacturer Date | 2010-01-18 |
| Date Added to Maude | 2012-08-16 |
| 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 | 9496801335 |
| 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 | 2012-02-09 |
| Returned To Mfg | 2012-01-26 |
| Model Number | 104-4112 |
| Lot Number | 8119140 |
| Device Expiration Date | 2012-11-01 |
| 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 | 2012-02-09 |