MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-14 for VITAPORT 9110 manufactured by Cook Pacemaker Corporation.
[11481]
This patient was noted to have non-functioning port-a-cath in her physicians office. She was schedulted for a contrast study to check for placement. This evaluation revealed transection of the catheter. It further identified a migration of the catheter 8-10cm into the right ventricle. The patient was asymptomatic. The catheter piece was removed without difficulty and a new catheter was inserted. The patient was discharged on 12/30/93.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 21249 |
| MDR Report Key | 21249 |
| Date Received | 1994-03-14 |
| Date of Report | 1994-01-04 |
| Date of Event | 1993-12-29 |
| Date Facility Aware | 1993-12-29 |
| Report Date | 1994-01-04 |
| Date Reported to Mfgr | 1994-01-04 |
| Date Added to Maude | 1995-04-20 |
| 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 |
| 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 | VITAPORT |
| Generic Name | PORT-A-CATH |
| Product Code | LKG |
| Date Received | 1994-03-14 |
| Model Number | 9110 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 21235 |
| Manufacturer | COOK PACEMAKER CORPORATION |
| Manufacturer Address | P.O. BOX 525 ROUTE 66 RIVER ROAD LEECHBURG PA 15656 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1994-03-14 |