MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-26 for COYOTE? ES H74939135304010 manufactured by Boston Scientific Corporation.
[103449203]
Patient Sequence No: 1, Text Type: N, H10
[103449204]
Inserted an angioplasty device (balloon) into a 6 fr sheath. Extended the angioplasty device down into the anterior tibial artery. Prior to inflating the device the tip of the device was sheared off and left in the vessel. The surgeon was able to snare the broken part of the device and extract it from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7369477 |
| MDR Report Key | 7369477 |
| Date Received | 2018-03-26 |
| Date of Report | 2018-03-12 |
| Date of Event | 2018-03-08 |
| Report Date | 2018-03-12 |
| Date Reported to FDA | 2018-03-12 |
| Date Reported to Mfgr | 2018-03-12 |
| Date Added to Maude | 2018-03-26 |
| 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 | 3 |
| 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 | COYOTE? ES |
| Generic Name | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
| Product Code | NVM |
| Date Received | 2018-03-26 |
| Model Number | H74939135304010 |
| Catalog Number | H74939135304010 |
| Lot Number | 21722151 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-26 |