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

Model Number 3600

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Embolism (1829)

Event Date 12/15/2020

Event Type  Injury  

Event Description

It was reported that the guidewire detached.A rotawire and wireclip torquer and 1.25mm rotalink plus were selected for an atherectomy procedure in the proximal left anterior descending artery (lad).There was low tortuosity with significant calcification.During the procedure, 8cm of the rotawire detached.The wire fragment migrated distally into the distal left anterior descending artery.Intervention was performed and the wire fragment was retrieved.The procedure was completed with another of the same device.There were no patient complications and the patient was ok post procedure.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11110245
• MDR Text Key: 224855212
• Report Number: 2134265-2020-18705
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195573
• UDI-Public: 08714729195573
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2021
• Device Model Number: 3600
• Device Catalogue Number: 3600
• Device Lot Number: 0024847610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention