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

Model Number	3241
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the break lock failed to hold the guidewire.A 1.75mm rotalink plus was selected for use.During the rotation, it was noted that the rotawire loosened.The procedure was completed with another of the same device.There were no complications reported.
Event or Problem Description
It was reported that the break lock failed to hold the guidewire.A 1.75mm rotalink plus was selected for use.During the rotation, it was noted that the rotawire loosened.The procedure was completed with another of the same device.There were no complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device found that the handshake connection was bent.The rotawire used in the procedure was not returned.So, functional testing consisted of using a test rotawire.The test wire was inserted into the annulus of the burr and advanced the through the advancer with resistance due to the bent handshake connection.Functional testing was then performed by connecting the advancer to the rotablator control console.During functional testing, the device was able to reach and maintain optimal rpm without unusual performance from the wire.During functional testing, the brake was activated and prevented the rotawire from advancing or retreating when the foot pedal was pressed, and the brake defeat button was not pressed down.Product analysis did not confirm the reported event, as the test wire was not able to move when the console foot pedal was pressed, and the brake defeat button was not pressed down.

• Brand Name: ROTALINK PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12222622
• Report Number: 2134265-2021-09529
• Device Sequence Number: 3723636
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0027235140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 07/24/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1