MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for IMPULSE 8120 manufactured by Boston Scientific Corporation.
[187886482]
Reported via mw5093185. It was reported that a piece of the device was in the right radial artery and surgery was performed to remove it. The target lesion was located in the right radial artery. A model 6f impulse catheter was selected for use to view the target lesion. During the procedure, when the patient was undergoing a cardiac catherization, it was noted that the sheath/wire broke off from the catheter. X-rays showed a small piece of the catheter most likely on the right radial artery. The following day, the vascular surgeon took the patient to surgery for the retained catheter in the right radial artery and performed cardiac intervention that consisted of right radial artery exploration and removal of a portion of the catheter and artery thrombectomy. No additional patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04126 |
| MDR Report Key | 9903417 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | AVAIL MEDICAL PRODUCTS INCORPO |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPULSE |
| Generic Name | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
| Product Code | DQO |
| Date Received | 2020-03-31 |
| Model Number | 8120 |
| Catalog Number | 8120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2020-03-31 |