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 2005-11-10 for DCS 18 2X4 HELICAL FILL 635F00204 manufactured by Cordis Neurovascular, Inc..
[433901]
This pt was undergoing coil embolization within the cavanous sinus through inferior petrosal sinus approach. There were no calcification and vessel tortuousity. After the physician placed the 4th dcs coil within the cavanous sinus, he pressurized the syringe and confirmed the gauge went down. After that, when he pulled the delivery tube, the end of the coil (about 5mm) remained in the microcatheter (mc). He pushed the coil with the gw and could place the coil into the cavanous sinus. After it was noticed that the gripper separated from the system. It's possible that the part remained in the pt's body, but couldn't be confirmed. There was no reported pt injury, the pt was stable and was discharged home soon after the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1058196-2005-00373 |
| MDR Report Key | 646359 |
| Report Source | 01,05,07 |
| Date Received | 2005-11-10 |
| Date of Report | 2005-11-10 |
| Date of Event | 2005-10-12 |
| Date Mfgr Received | 2005-10-12 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2005-11-18 |
| 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 |
| 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 | DCS 18 2X4 HELICAL FILL |
| Generic Name | CNV DCS COILS |
| Product Code | HCS |
| Date Received | 2005-11-10 |
| Model Number | NA |
| Catalog Number | 635F00204 |
| Lot Number | 13010886 |
| ID Number | NA |
| Device Expiration Date | 2006-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 635864 |
| Manufacturer | CORDIS NEUROVASCULAR, INC. |
| Manufacturer Address | * MIAMI LAKES FL 33125 US |
| Baseline Brand Name | DCS 18 2X4 HELLICAL FILL |
| Baseline Generic Name | CNV DCS COILS |
| Baseline Model No | NA |
| Baseline Catalog No | 635F00204 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-11-10 |