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 2011-10-14 for HYPERFORM OCCLUSION BALLOON SYSTEM 104-4370 manufactured by Ev3 Neurovascular.
[19331801]
The catheter was returned with an unk substance inside the balloon lumen. The substance was analyzed and found to be iodinated organic compound which consistent with what is used during clinical procedure. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[19362688]
During preparation, it was reported the balloon could not be deflated as there was an unk substance found inside the catheter. The device was not used in the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2011-00334 |
| MDR Report Key | 2371410 |
| Report Source | 04,05,06 |
| Date Received | 2011-10-14 |
| Date of Report | 2011-09-15 |
| Date of Event | 2011-08-12 |
| Date Mfgr Received | 2011-09-15 |
| Device Manufacturer Date | 2011-03-15 |
| Date Added to Maude | 2012-03-13 |
| 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 | NUF |
| Date Received | 2011-10-14 |
| Returned To Mfg | 2011-09-29 |
| Model Number | 104-4370 |
| Lot Number | 9415111 |
| Device Expiration Date | 2013-03-01 |
| Operator | OTHER |
| Device Availability | Y |
| 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 | 2011-10-14 |