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

Model Number 3320

Device Problems Entrapment of Device (1212); Connection Problem (2900); Output Problem (3005); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2020

Event Type  malfunction  

Event Description

It was reported that there was difficulty removing the device.A 1.50mm rotapro and rotawire were selected for use with a guidezilla in a heavily calcified lesion in the mid-right coronary artery (rca), with significant calcified lesions in the distal rca.Of note, there was a calcific tortuous lesion in the proximal rca with previously implanted stents mid-segment.During the procedure, the rotapro decelerated and became stalled in the mid-rca.Dynaglide mode was activated however, when the burr exited the distal lumen of the guidezilla, the rotapro stalled against the hypotube of the catheter.The burr was attempted to be removed over the wire manually, but it was unable to be done so the burr and wire were removed from the patient body together.Upon inspection after removal it was discovered that the distal tip of the guidezilla was damaged due to friction between the guidezilla and rotapro shaft.A 1.75mm rotapro and new rotawire were selected to continue the case, and advanced to the mid-rca where the device experienced unstable speed issues.The physician was unable to remove the device using the advancer knob.The system did not stall and when activated would rotate at 200 rpms and the system made a different sound than usual.It was identified that the connection failed, and the system was removed from the patient.The procedure was completed using an alternative method.Post procedure, a good angiographic result was achieved.No patient complications were reported and patient was reported as well at the end of the procedure.

• Brand Name: ROTALINK BURR
• 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; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9922641
• MDR Text Key: 186545575
• Report Number: 2134265-2020-04392
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185840
• UDI-Public: 08714729185840
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 04/03/2020

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 Expiration Date: 07/23/2021
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0024317288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2019
• 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