MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for COOK G03117 C-PMS-301J-PED manufactured by Cook Incorporated.
[185050951]
Central venous catheter was placed in patients lijv (left internal jugular vein). After the catheter was sutured in place the cardiac cath fellow attempted to flush the line. This attempt was unsuccessful and the catheter appeared to be kinked at the incision site. The fellow attempted to straighten the catheters kink in hopes that would solve the occlusion problem. Once the catheter was straightened out it appeared to break, leaving the intravascular portion lodged in the vein. Doctor was paged to come remove the retained catheter. While attempting the removal, the retained portion broke free and traveled to the patients right atrium. Another doctor then successfully removed the broken catheter from the right atrium using a intravascular snare and angiographic catheter. Staff then proceeded to reconstruct the patients lijv. Patient needed central venous access during cardiac cath procedure. After collecting the components of the catheter, the team felt their may have been a device failure as these catheters generally have more integrity. The device was placed in a biohazard bag and will be sent to cook medical.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9882747 |
| MDR Report Key | 9882747 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-10 |
| Report Date | 2020-02-26 |
| Date Reported to FDA | 2020-02-26 |
| Date Reported to Mfgr | 2020-03-26 |
| Date Added to Maude | 2020-03-26 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK |
| Generic Name | CATHETER, PERCUTANEOUS |
| Product Code | DQY |
| Date Received | 2020-03-26 |
| Model Number | G03117 |
| Catalog Number | C-PMS-301J-PED |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INCORPORATED |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |