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 2020-03-30 for ROTAPRO 3243 manufactured by Boston Scientific Corporation.
[187712265]
Age at time of event: 18 years or older.
Patient Sequence No: 1, Text Type: N, H10
[187712266]
It was reported that a perforation occurred. The target lesion was located in the mildly tortuous and heavily calcified right coronary artery. A 1. 50mm rotapro, rotawire and a bsc y adapter hemostasis valve was used for the procedure. Proper technique and pecking motion were used, decelerations were monitored without continuing to advance when decelerations were noted. No kinks or difficulty backloading the wire were identified. During the fourth run at under 30 seconds each, the guidewire broke and the burr perforated the artery. The distal part of the wire remained in the coronary artery and patient was sent to the operating room to recover the wire and repair the perforation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04038 |
| MDR Report Key | 9897946 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-12-12 |
| Date Added to Maude | 2020-03-30 |
| 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 IRELAND |
| Manufacturer Country | EI |
| Manufacturer Postal Code | IRELAND |
| 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 | 2020-03-30 |
| Model Number | 3243 |
| Catalog Number | 3243 |
| Lot Number | 0024922484 |
| 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 | 2020-03-30 |