MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-08-05 for TRUFILL DCS ORIBIT 3X6 HELICAL FILL 637HF0306 manufactured by Cordis Neurovascular, Inc..
[421889]
This report received indicated that during coil emobolization of an anterior communicating artery aneurysm, a section of the coil protruded and remains in the parent artery. During placement of the last coil, the microcatheter slipped out of the aneurysm. An effort was made to reposition the microcatheter by forwarding the microcatheter and at the same time withdrawing the coil into the microcatheter; however, this failed. The detachment marker remained at the spot of the siphon. This resulted in the coil being 2/3rd within the aneurysm and 1/3rd within the internal carotid artery. It was reported that the proximal end has a lower density. It was thought that possibly friction was related to this event. This product has been returned for evaluation and testing, however the engineer's report is not yet complete.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1016427-2005-00187 |
| MDR Report Key | 624930 |
| Report Source | 07 |
| Date Received | 2005-08-05 |
| Date of Report | 2005-08-05 |
| Date of Event | 2005-06-30 |
| Date Mfgr Received | 2005-07-07 |
| Date Added to Maude | 2005-08-10 |
| 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 | THOMAS MORRISSEY, MD, 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 | 14000 NW 57 CT |
| Manufacturer City | MIAMI LAKES FL 33125 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33125 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUFILL DCS ORIBIT 3X6 HELICAL FILL |
| Generic Name | CNV DCS ORIBIT |
| Product Code | HGC |
| Date Received | 2005-08-05 |
| Returned To Mfg | 2005-07-19 |
| Model Number | NA |
| Catalog Number | 637HF0306 |
| Lot Number | 13033358 |
| ID Number | NA |
| Device Expiration Date | 2007-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 614555 |
| Manufacturer | CORDIS NEUROVASCULAR, INC. |
| Manufacturer Address | * MIAMI LAKES FL 33125 US |
| Baseline Brand Name | TRUFILL DCS ORIBIT 3X6 HELICAL FILL |
| Baseline Generic Name | CNV DCS ORIBIT |
| Baseline Model No | NA |
| Baseline Catalog No | 637HF0306 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2005-08-05 |