MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-05 for PERCLOSE THE CLOSER S 6 FR. * manufactured by Abbott Laboratories.
[20928004]
Procedure: stent placement, proximal right coronary artery. After the sheath was removed a perclose suture delivery system was placed in the right femoral artery without difficulty and the suture was deployed. After deployment the suture delivery system could not be removed. Using fluoroscopy it was determined the device had separated into 2 pieces. Multiple attempts were made to manually remove the suture delivery system. The suture was able to be successfully removed but not the device. The device was then removed by cutdown procedure in the or. There was no flow compromise to the extremity and the pt tolerated the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1031108 |
| MDR Report Key | 511454 |
| Date Received | 2004-02-05 |
| Date of Report | 2004-02-05 |
| Date of Event | 2004-02-02 |
| Date Added to Maude | 2004-02-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERCLOSE |
| Generic Name | SUTURE DELIVERY SYSTEM |
| Product Code | MAB |
| Date Received | 2004-02-05 |
| Model Number | THE CLOSER S 6 FR. |
| Catalog Number | * |
| Lot Number | 09002-6H |
| ID Number | REF # 12359 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 500423 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 200 ABBOTT PARK ABBOTT PARK IL 600646135 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-02-05 |