MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER; CATHETER, PERIPHERAL, ATHERECTOMY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The wire was unable to be removed from the separated rotalink coil due to the severe coil stretching.There are numerous kinks along the body of the wire.Dimensional inspection of the wire that could be measured were performed and were within specification.

Event Description

Reportable based on device analysis completed on 25nov2019.A peripheral rotawire was received with device from report # 2134265-2019-13197 with no reported issues.However, device analysis revealed that the wire was entrapped with the burr.

• Brand Name: PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9437380
• MDR Text Key: 175899257
• Report Number: 2134265-2019-15236
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR