MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-18 for BOSTON SCIENTIFIC / TARGET THERAPEUTICS GDC 18-SOFT 351615-4 manufactured by Target Therapeutics/boston Scientific.
[19152414]
Premature detachment of boston scientific/target therapeutics gdc embolization coil. The pt had an occlusive dissection of the internal carotid artery with an associated pseudoaneurysm. A cordis prowler 14 microcatheter was placed inside the pseudoaneurysm prior to deployment of two cordis precise stents to reopen the lumen of the carotid artery. A target therapeutics gdc 18-soft 6 x 15 mm coil, lot #4457610, ref #351615-1 was then prepped and placed into the microcatheter for embolization of the pseudoaneurysm. Midway through the microcatheter on the initial placement attempt the coil became very difficult to push. On withdrawal of the pusher wire it was apparent that the coil had detached prematurely from the pusher wire. The microcatheter was withdrawn with the coil still lodged inside. A second catheter was placed in the pseudoaneurysm which was subsequently coiled with good result. There was no clinical complications associated with this event. The catheter and coil have been sent to target therapeutics for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1024813 |
| MDR Report Key | 390244 |
| Date Received | 2002-04-18 |
| Date of Report | 2002-04-18 |
| Date of Event | 2002-03-26 |
| Date Added to Maude | 2002-04-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOSTON SCIENTIFIC / TARGET THERAPEUTICS |
| Generic Name | GDC 18-SOFT PLATINUM EMBOLIZATION COIL |
| Product Code | HDC |
| Date Received | 2002-04-18 |
| Returned To Mfg | 2002-04-18 |
| Model Number | GDC 18-SOFT |
| Catalog Number | 351615-4 |
| Lot Number | 4457610 |
| ID Number | * |
| Device Expiration Date | 2004-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 379291 |
| Manufacturer | TARGET THERAPEUTICS/BOSTON SCIENTIFIC |
| Manufacturer Address | 47900 BAYSIDE PKWY FREMONT CA 945386515 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-04-18 |