MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-25 for ROTAPRO 3243 manufactured by Boston Scientific Corporation.
[185042725]
It was reported that the burr and wire became stuck in the lesion. A 1. 75mm rotapro and rotawire floppy 330cm was selected for a percutaneous coronary intervention (pci) procedure in the mid left anterior descending (lad) artery. When the user attempted to withdraw the device, it was noted that the burr was stuck in the lesion. The rotapro and rotawire were removed successfully from the patient body. The procedure was completed by using another of the same device. Patient condition was good, and no complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03792 |
| MDR Report Key | 9878126 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-12-04 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| 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 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTAPRO |
| Generic Name | CATHETER, CORONARY, ATHERECTOMY |
| Product Code | MCX |
| Date Received | 2020-03-25 |
| Model Number | 3243 |
| Catalog Number | 3243 |
| Lot Number | 0024873775 |
| 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 | 2020-03-25 |