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

Model Number 3520

Device Problem Entrapment of Device (1212)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the burr detached and the patient became unstable.The target lesion was located in the mid left anterior descending artery.A 1.25mm rotalink plus and rotawire were selected for use.When burr was withdrawn, the burr became detached form the shaft and was stuck on the rotawire.The burr was retrieved by pulling back on the rotawire into the guide catheter and successfully removed adding 30 minutes to the case.At the time of burr detachment, the patient became unstable, but was fine after the device was retrieved.

• 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 DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; two scimed place; ,; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8232862
• MDR Text Key: 132574544
• Report Number: 2134265-2019-00001
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/09/2019

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
• Device Model Number: 3520
• Device Catalogue Number: 3520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2018
• Initial Date FDA Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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