MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2005-02-21 for TRUFILL DCS ORBIT 3X8 HELICAL FILL 637HF0308 manufactured by Cordis Neurovascular, Inc..
[17017467]
The coil stretched.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1058196-2005-00014 |
| MDR Report Key | 580999 |
| Report Source | 01,05,07 |
| Date Received | 2005-02-21 |
| Date of Report | 2005-02-17 |
| Date of Event | 2005-01-18 |
| Date Facility Aware | 2005-01-18 |
| Report Date | 2005-02-17 |
| Date Reported to Mfgr | 2005-02-18 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2005-03-15 |
| 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 | 3 |
| Manufacturer Contact | THOMAS MORRISSEY, MED DIRECTOR |
| Manufacturer Street | 14201 NW 60TH AVE |
| 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 | 2005-02-21 |
| Model Number | NA |
| Catalog Number | 637HF0308 |
| Lot Number | 13002485 |
| ID Number | NA |
| Device Expiration Date | 2006-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 570838 |
| 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 | 2005-02-21 |