MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-21 for MEWISSEN INFUSION CATHETER 46-411 manufactured by Medi-tech.
[19782636]
Cath used by radiologist to instill thrombolytic med into thrombus occluding rt. Fem/pop graft. When the cath was withdrawn, one of the length markers was missing and could be seen within the vessel via fluoroscopy. A larger sheath and "stone basket" instrument was used ot retrieve the marker with prolonged effort and manipulation. The patient was taken to the or for general anesthesia and surgical repair of the large hole inm the vessel and removal of the thrombus. She was discharged to home onm 2/5/94.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16041 |
| MDR Report Key | 16041 |
| Date Received | 1994-07-21 |
| Date of Report | 1994-02-11 |
| Date of Event | 1994-02-03 |
| Date Facility Aware | 1994-02-03 |
| Report Date | 1994-02-11 |
| Date Reported to Mfgr | 1994-02-11 |
| Date Added to Maude | 1994-09-13 |
| 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 | MEWISSEN INFUSION CATHETER |
| Generic Name | ANGIOGRAPHY INFUSION CATHETER |
| Product Code | JCY |
| Date Received | 1994-07-21 |
| Returned To Mfg | 1994-02-11 |
| Catalog Number | 46-411 |
| Lot Number | 100905 |
| ID Number | 100CM. 5F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15974 |
| Manufacturer | MEDI-TECH |
| Manufacturer Address | 480 PLEASANT ST. WATERTOWN MA 02172* US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 1994-07-21 |