MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-22 for MEDTRONIC DLP UNK * manufactured by Medtronic.
[294912]
A patient underwent cabg with left atrial catheter inserted in 2003. The device was removed the next day. During a follow-up visit, a transthoracic echocardiography (tee) showed a left atrial mass, which was confirmed to be the left atrial catheter. The catheter broke at midline per physician. Fluoroscopy showed the device to have torn off in the right subcostal area. When the device was removed, it was believed that the entire catheter had been removed. There is no coloring or marking on the tip of the catheter that allows one to identify that the entire catheter has been removed. Also, the catheter can readily be stretched from its length of 12 inches to about 18 inches without breaking. Furthermore, the tip is not radiopaque so it can't be identified on x-ray. The patient was taken for elective surgical removal 6 months later. Device usage problem: device failed (e. G broke, couldn't get it to work or stopped working).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 490380 |
| MDR Report Key | 490380 |
| Date Received | 2003-10-22 |
| Date of Report | 2003-07-01 |
| Date of Event | 2003-01-01 |
| Date Added to Maude | 2003-10-23 |
| 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 | MEDTRONIC DLP |
| Generic Name | PRESSURE CATHETER PLACEMENT SET |
| Product Code | DXS |
| Date Received | 2003-10-22 |
| Model Number | UNK |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 479114 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | 7000 CENTRAL AVENUE, NE MAIL STOP: CW 305 (CRM WEST) MINNEAPOLIS MN 554323576 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-10-22 |