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 2005-07-27 for TRUFILL DCS ORBIT 3X8 HELICAL FILL 637HF0308 manufactured by Cordis Neurovascular, Inc..
[421529]
The report company received from the affiliate indicated that the coil system failed to rezip during attempts to remove the system. The procedure was a carotid cavernous fistula. The 3x8 orbit coil was first used, but the physician decided to change it to another size. He reversed that steps and re-sheathed the coil; however, when he tried to rezip the unit using the orange zipper, it failed to move from its proximal location. The physician finally decided to pull the entire system out. There was no report of patient injury. The product is available for evaluation and testing; however, it has not been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1058196-2005-00313 |
| MDR Report Key | 627817 |
| Report Source | 01,05,07,08 |
| Date Received | 2005-07-27 |
| Date of Report | 2005-07-27 |
| Date of Event | 2005-06-28 |
| Date Mfgr Received | 2005-06-29 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2005-08-19 |
| 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 | THOMAS MORRISSEY, MD |
| 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 ORBIT 3X8 HELICAL FILL |
| Generic Name | CNV DCS ORBIT |
| Product Code | HGC |
| Date Received | 2005-07-27 |
| Model Number | NA |
| Catalog Number | 637HF0308 |
| Lot Number | 13000541 |
| ID Number | NA |
| Device Expiration Date | 2006-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 617448 |
| Manufacturer | CORDIS NEUROVASCULAR, INC. |
| Manufacturer Address | * MIAMI LAKES FL 33125 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 | 2005-07-27 |