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

Model Number	3241
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the burr got stuck on rotawire.A 1.75mm rotalink plus and rotawire (extra support) were selected for use.After ablation, the burr was removed.However, it got stuck with the guidewire.The devices were removed from the patient together as one unit, then the procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr, and annulus were visually and microscopically examined.Inspection of the device presented no damage or irregularities to the rotablator rotalink plus device.However, the returned rotawire had a severe kink in the proximal end.Functional testing consisted of attempting to remove the rotawire from the rotapro device.The wire was able to be removed, but there was severe resistance due to the kink in the proximal end of the wire.
Event or Problem Description
It was reported that the burr got stuck on rotawire.A 1.75mm rotalink plus and rotawire (extra support) were selected for use.After ablation, the burr was removed.However, it got stuck with the guidewire.The devices were removed from the patient together as one unit, then the procedure was completed with another of the same device.There were no patient complications reported.

• 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: 11616185
• Report Number: 2134265-2021-04185
• Device Sequence Number: 2998692
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 08/19/2022
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0026039842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1