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 2005-07-14 for TRUFILL DCS ORBIT 637HF0308 manufactured by Cordis Neurovascular, Inc..
[426471]
The report received form the affiliate indicated that the procedure was embolization of a right internal carotid artery aneurysm, which was previously treated with gdc coils and neuroform stent 15 days prior to this index procedure. The physician inserted four orbit coild in the aneurysm. However, the fifth coil stretched without resistance, and protruded into the external carotid artery. There were two loops in the aneurysm and other part of the stretched coil remains in the external carotid artery, as the physician could not remove the stretched coil.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1058196-2005-00308 |
| MDR Report Key | 621746 |
| Report Source | 01,05,07,08 |
| Date Received | 2005-07-14 |
| Date of Report | 2005-07-14 |
| Date of Event | 2005-06-29 |
| Date Mfgr Received | 2005-06-29 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2005-07-20 |
| 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 NEUROVASUCLAR |
| Manufacturer Street | 14000 NW 57CT |
| Manufacturer City | MIAMI LAKES FL 33125 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33125 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUFILL DCS ORBIT |
| Generic Name | CNV DCS ORBIT |
| Product Code | HGC |
| Date Received | 2005-07-14 |
| Model Number | NA |
| Catalog Number | 637HF0308 |
| Lot Number | 13030243 |
| ID Number | NA |
| Device Expiration Date | 2007-02-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 611394 |
| 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 | 1. Other; 2. Required No Informationntervention | 2005-07-14 |