MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-18 for ARROW INTERNATIONAL manufactured by Arrow International.
[15201]
Right subclavian catheter placed. Inserted needle under clavicle; guidewire kinked. Catheter wouldn't go in. Physician tried to remove guidewire and catheter together. Unable to remove without force. On chest xray for placement of catheter, portion of guidewire noted to be retained. Following the surgical procedure, the patient was taken to cardiac catheterization for removal of retained wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 25736 |
| MDR Report Key | 25736 |
| Date Received | 1995-01-18 |
| Date of Report | 1994-10-10 |
| Date of Event | 1994-10-03 |
| Date Facility Aware | 1994-10-03 |
| Report Date | 1994-10-10 |
| Date Reported to Mfgr | 1994-10-14 |
| Date Added to Maude | 1995-09-19 |
| 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 | ARROW INTERNATIONAL |
| Generic Name | DOUBLE LUMEN CATHETER |
| Product Code | FGH |
| Date Received | 1995-01-18 |
| ID Number | PRODUCT #AK 14402 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 26318 |
| Manufacturer | ARROW INTERNATIONAL |
| Manufacturer Address | 3000 BERNVILLE RD. REDDING PA 19605 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-01-18 |