MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-12-05 for IDC-INTERLOCKING DETACHABLE COIL * 360202 manufactured by Boston Scientific Corp. Neurovascular Div..
[19494593]
Device was advanced and pulled back into the renegade 18 microcatheter, resistance was felt. Although, attempts were made to remove coil, it got stuck at the distal tip of the microcatheter. When the coil was pulled back with force, the tip of the pusher wire got stretched and the coil was inserted into the aneurysm. No complications were reported to have occurred with the patient during this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000078-2005-00246 |
| MDR Report Key | 651342 |
| Report Source | 07 |
| Date Received | 2005-12-05 |
| Date of Report | 2005-12-02 |
| Date of Event | 2005-09-20 |
| Date Mfgr Received | 2005-09-20 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2005-12-13 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | ALEN KRIKORIAN |
| Manufacturer Street | 47900 BAYSIDE PARKWAY |
| Manufacturer City | FREEMONT CA 945386515 |
| Manufacturer Country | US |
| Manufacturer Postal | 945386515 |
| Manufacturer Phone | 8006622415 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDC-INTERLOCKING DETACHABLE COIL |
| Generic Name | DETACHABLE COIL |
| Product Code | HGC |
| Date Received | 2005-12-05 |
| Returned To Mfg | 2005-10-12 |
| Model Number | * |
| Catalog Number | 360202 |
| Lot Number | 7737263 |
| ID Number | * |
| Device Expiration Date | 2008-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 640811 |
| Manufacturer | BOSTON SCIENTIFIC CORP. NEUROVASCULAR DIV. |
| Manufacturer Address | * FREEMONT CA * US |
| Baseline Brand Name | IDC-INTERLOCKING DETACHABLE COIL |
| Baseline Generic Name | DETACHABLE COIL |
| Baseline Model No | * |
| Baseline Catalog No | 360202 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-12-05 |