MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-20 for BOSTON SCIENTIFIC PIG 145 IMPULSE 6 FR manufactured by Boston Scientific Corporation.
[180780187]
Patient undergoing a cardiac catherization when a shearing of the sheath/wire broke off from the cath on the right radial artery. X-rays showed a small piece of the catheter most likely in the right radial artery. Vascular surgery was consulted. The vascular surgeon took patient to surgery the following day for the retained catheter in the right radial artery. The cardiac intervention by the vascular surgeon consisted of right radial artery exploration and removal of a portion of the catheter and radial artery thrombectomy. Physician performing cardiac cath reported to be an experienced operator and it is believed event is possibly due to device failure. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093185 |
| MDR Report Key | 9739785 |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-06 |
| Date Added to Maude | 2020-02-21 |
| 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 | RISK MANAGER |
| 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 | BOSTON SCIENTIFIC PIG 145 IMPULSE 6 FR |
| Generic Name | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
| Product Code | DQO |
| Date Received | 2020-02-20 |
| Model Number | PIG 145 |
| Lot Number | H74916599410 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-20 |