MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,08 report with the FDA on 2006-04-18 for TRUFILL DCS ORBIT 3X8 HELICAL FILL 637HF0308 manufactured by Cordis Neurovascular, Inc..
[18915314]
The report we received from our affiliate indicated that during embolixation of a cerebral aneurysm, the 3rd coil being placed stretched and broke during attempts to reposition it. The physician was attempting to bring the coil back into the microcatheter in order to reposition the coil, and as per the reporting affiliate, a one relation between the coil nad the micorcatheter was verified on flouro prior to this withdrawal. However, although no resistance was noted, the coil did not respond; it stretched and then broke down at the level of the gripper and stayed in the carotid artery. The physician attempted to retrieve the broken soil with a snare, but was unsuccessful. The product is not available for evaluation and testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1058196-2006-00069 |
| MDR Report Key | 702070 |
| Report Source | 01,05,07,08 |
| Date Received | 2006-04-18 |
| Date of Report | 2006-04-18 |
| Date of Event | 2006-03-27 |
| Date Mfgr Received | 2006-03-27 |
| Device Manufacturer Date | 2003-03-01 |
| Date Added to Maude | 2006-04-24 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. THOMAS MORRISSEY, MED DIR |
| Manufacturer Street | 14201 NW 60TH AVENUE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal | 33014 |
| Manufacturer Phone | 7863132516 |
| Manufacturer G1 | CORDIS NEUROVASCULAR, INC. |
| Manufacturer Street | 14700 NW 57TH COURT |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUFILL DCS ORBIT 3X8 HELICAL FILL |
| Generic Name | CNV DCS ORBIT |
| Product Code | HGC |
| Date Received | 2006-04-18 |
| Model Number | NA |
| Catalog Number | 637HF0308 |
| Lot Number | 13037469 |
| ID Number | PART#:NA |
| Device Expiration Date | 2007-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 691181 |
| Manufacturer | CORDIS NEUROVASCULAR, INC. |
| Manufacturer Address | * MIAMI LAKES FL 33014 US |
| Baseline Brand Name | TRUFILL DCS ORBIT MINI COMPLEX FILL |
| Baseline Generic Name | TRUFILL DCS ORBIT MINI COMPLEX FILL |
| Baseline Model No | NA |
| Baseline Catalog No | 637HF0308 |
| Baseline ID | NA |
| Baseline Device Family | CES EMBOLIC COILS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K032553 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-04-18 |