MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for TERUMO AZUR CX DETACH 18 PERIPH HYDRO COIL (01) 00816777024367 45_780202 manufactured by Terumo Medical Canada, Inc..
[184477450]
Interventional radiology tech opened and saw that a coil was missing. She then removed the packet from the prep table and opened. We were recently alerted to an issue w/ terumo coils that the actual coil may be missing from the item. The recs were to tag affected product and instruct the md to visually inspect before using. All protocols were followed, but a missing coil was noted. The vendor has been contacted and a replacement is being sent. This product was intended for an interventional radiology procedure at the robley rex va medical center in louisville, ky. The ir tech opened a second coil packet and the pt procedure was started and completed. The missing coil packet was set aside for the vendor to pick up. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093839 |
| MDR Report Key | 9853338 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-03-12 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERUMO AZUR CX DETACH 18 PERIPH HYDRO COIL |
| Generic Name | DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION |
| Product Code | KRD |
| Date Received | 2020-03-18 |
| Model Number | (01) 00816777024367 |
| Catalog Number | 45_780202 |
| Lot Number | 1903135Z8 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO MEDICAL CANADA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2020-03-18 |