MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-03-09 for TRUFILL DCS ORBIT 3X8 HELICAL FILL 637HF0308 manufactured by Cordis Neurovascular, Inc..
[15448556]
This patient with a history of intense migraines was diagnosed via ct scan with a subarrachnoid hemorrhage-fischer ii & hunt & hess ii. The angiogram showed aneurysm of the 1/3 upper of the basilar trunk. Prior to the procedure the patient was conscious without any deficit. The access site was right femoral artery, target site was 1/3 distal basilar trunk, 2mm x 3. 2mm. There was no resistance inserting the coil throught he rhv valve and a continuous flush was maintained. During the 1st coil placement, resistance was felt during advancing/withdrawing the coil into the boston scienctific microcatheter. With insertion of the last mm of the coil, the end of the microcatheter pushed out into the principal artery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1058196-2006-00048 |
| MDR Report Key | 687133 |
| Report Source | 05,07 |
| Date Received | 2006-03-09 |
| Date of Report | 2006-03-09 |
| Date of Event | 2006-02-09 |
| Report Date | 2006-03-09 |
| Date Mfgr Received | 2006-02-10 |
| Date Added to Maude | 2006-03-16 |
| 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 | 3 |
| Manufacturer Contact | DR. THOMAS MORRISSEY, MEDICAL 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 | 2006-03-09 |
| Model Number | NA |
| Catalog Number | 637HF0308 |
| Lot Number | 13046341 |
| ID Number | PART #:NA |
| Device Expiration Date | 2007-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 676337 |
| 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 | 1. Other | 2006-03-09 |