MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY

Device Problems Difficult to Remove (1528); Output Problem (3005)

Patient Problems Chest Pain (1776); ST Segment Elevation (2059)

Event Date 10/15/2020

Event Type  Injury  

Event Description

It was reported that the burr was difficult to remove.A rotalink plus rotablator rotational atherectomy system were selected for use.After the third passage, the burr unexpectedly stopped downstream from the lesion.Several attempts were made to start rotation, however, rotation stopped within 5 seconds.Dynaglide function was not working.It was not possible to remove the burr and the patient experienced st segment elevation coronary syndrome and chest pain.The patient required deep intubation, sedation, injection of arterial vasodilators, and parallel placement of a guide in order to remove the burr from the circumflex artery.No further patient complications were reported.

• Brand Name: ROTALINK PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11211089
• MDR Text Key: 228166667
• Report Number: 2134265-2021-00614
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention