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 2020-03-31 for ROTAWIRE AND WIRECLIP TORQUER 3520 manufactured by Boston Scientific Corporation.
[185943803]
Device evaluated by mfr: the device was returned for analysis. Visual inspection of the returned guidewire showed its body was kinked approximately at 269cm from the proximal end. The core wire was broken approximately at 329cm from the proximal end; another section was attached to the distal solder ball and it measured approximately 1cm. The distal tip of the guidewire was stretched. No more damages were found in the device. Dimensional inspection of the overall length and the outer diameter (od) of distal tip could not be performed due to device condition. The od of the middle and proximal section of the device were within specification. No other issues were identified during the product analysis.
Patient Sequence No: 1, Text Type: N, H10
[185943804]
Reportable based on device analysis completed on 17mar2020. It was reported that the rotawire could not advance through the burr. The 90% stenosed target lesion was located in the severely tortuous and calcified left anterior descending artery. A 330cm rotawire was selected for use. During the procedure, it was noted that the rotawire could not cross the burr. The procedure was completed with another of the same device. No patient complications were reported and the patient was stable post procedure. However, device analysis revealed that the core wire was broken at approximately 329 cm from the proximal end.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04080 |
| MDR Report Key | 9903391 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2019-05-24 |
| 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 |
| 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 | 2020-03-31 |
| Returned To Mfg | 2020-03-04 |
| Model Number | 3520 |
| Catalog Number | 3520 |
| Lot Number | 0023851540 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-31 |