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 2020-03-23 for ROTAWIRE AND WIRECLIP TORQUER 3520 manufactured by Boston Scientific Corporation.
[184460788]
Device evaluated by mfr: the device was returned for analysis. The guidewire returned together with its original opened pouch. The guidewire body was found kinked in different sections of its body located approximately at 34. 5 cm, 71. 5 cm, 98 cm, 136 cm and 196. 5 cm from the proximal end. The spring tip was found detached from the core wire and it was not returned. The core wire was fractured and it measured approximately 328. 6 cm from the proximal end; the detached section was not returned. No more damages were found in the device. Dimensional inspection of outer diameter (od) of the middle and proximal section the wire was performed and were within specification. However, the overall length and od of the distal tip could not be performed due to the device condition.
Patient Sequence No: 1, Text Type: N, H10
[184460789]
Reportable based on device analysis completed on (b)(6) 2020. It was reported that the wire shaft was kinked. A 330cm rotawire was selected for use. Upon preparation, it was noted that the wire shaft became kinked at the middle part. The procedure was completed with a different device. There were no patient complications reported. However, device analysis revealed spring tip detachment and core wire fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03660 |
| MDR Report Key | 9865258 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-08-09 |
| Date Added to Maude | 2020-03-23 |
| 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 | 2020-03-23 |
| Returned To Mfg | 2020-02-20 |
| Model Number | 3520 |
| Catalog Number | 3520 |
| Lot Number | 0024241666 |
| 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 | 2020-03-23 |