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 2020-03-26 for ROTAWIRE AND WIRECLIP TORQUER 3600 manufactured by Boston Scientific Corporation.
[186522235]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[186522236]
It was reported that a rotawire fracture occurred. A rotawire and rotablator rotational atherectomy system were selected for use. During procedure, it was noted that the device got separated during rotablation and was retrieved completely from the patient using gooseneck snare. However, it was further reported that there was no issue noted with the rotaburr. The procedure was completed with another device. No patient complications were reported. Patient has no problem and was good post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03842 |
| MDR Report Key | 9883411 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-11-28 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-06-11 |
| Date Added to Maude | 2020-03-26 |
| 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 DE COSTA RICA S.R.L |
| Manufacturer Street | 302 PARKWAY, GLOBAL PARK |
| Manufacturer City | LA AURORA - HEREDIA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTAWIRE AND WIRECLIP TORQUER |
| Generic Name | CATHETER, CORONARY, ATHERECTOMY |
| Product Code | MCX |
| Date Received | 2020-03-26 |
| Model Number | 3600 |
| Catalog Number | 3600 |
| Lot Number | 0023937216 |
| 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 | 2020-03-26 |