MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-24 for ARROW/COOK NI manufactured by Arrow/cook.
[1860]
Physician inserted arrow triple lumen subclavian catheter. The guide wire became bent and was disposed of. A replacement guide wire - cook guide wire was used. Both catheter and wire became knotted in jugular vein. Patient went to or for removal of catheter and wire. Device labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown, guidewire, other. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4060 |
| MDR Report Key | 4060 |
| Date Received | 1992-07-24 |
| Date of Event | 1992-02-18 |
| Date Facility Aware | 1992-02-18 |
| Date Reported to Mfgr | 1992-02-25 |
| Date Added to Maude | 1993-05-13 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW/COOK |
| Generic Name | ARROW TRIPLE LUMEN SUBCLAVIAN CATHETER/J TIP GUIDE WIRE |
| Product Code | GBP |
| Date Received | 1992-07-24 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 3793 |
| Manufacturer | ARROW/COOK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-24 |