MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-13 for COOK SPECTRUM VENTRICULAR CATHETER * manufactured by Cook Medical.
[18972251]
A central venous line was placed via femoral access using the cook medical spectrum cv tray. The vein was accessed without difficulty. The guidewire was also advanced without difficulty and the md used a scalpel to increase the incision around the guidewire with the blade up. A dilator was used to dilate the space and the catheter was advanced over the guidewire. The md was unable to withdraw the guidewire. Upon removal of the catheter the md observed that the guidewire was unraveled. A kub was ordered and performed indicating retained unraveled guidewire. The patient was transferred to the cardiac catheterization lab to remove the retained guidewire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2422087 |
| MDR Report Key | 2422087 |
| Date Received | 2012-01-13 |
| Date of Report | 2012-01-13 |
| Date of Event | 2012-01-02 |
| Report Date | 2012-01-13 |
| Date Reported to FDA | 2012-01-13 |
| Date Added to Maude | 2012-01-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK SPECTRUM VENTRICULAR CATHETER |
| Generic Name | CVL GUIDEWIRE |
| Product Code | NHC |
| Date Received | 2012-01-13 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | C-UYLMY-701J-RCS-ABRM-HC-FSTRD |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Age | 9 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-13 |