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

Model Number	3241
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was difficult to remove.The target lesion was located in the severely calcified right coronary artery.A 2.00mm rotalink plus was selected for use.During procedure, it was noted that the guide catheter was kinked and the burr was difficult to remove.The device was removed together with the whole system.The guide catheter was changed and the procedure was completed using the original device.No patient complications were reported.
Event or Problem Description
It was reported that the burr was difficult to remove.The target lesion was located in the severely calcified right coronary artery.A 2.00mm rotalink plus was selected for use.During procedure, it was noted that the guide catheter was kinked and the burr was difficult to remove.The device was removed together with the whole system.The guide catheter was changed and the procedure was completed using the original device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.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 device.However, the returned guide catheter had a severe kink in the lumen.The internal diameter (id) of the guide was.083 inch.As the guide catheter used in the procedure was returned with the rotablator device, it was used for functional testing.Functional testing consisted of inserting the burr into the hub of the device; however, the burr won't pass the kink.

• 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: 11197676
• Report Number: 2134265-2021-00372
• Device Sequence Number: 3756176
• Product Code: MCX
• UDI-Device Identifier: 08714729316442
• UDI-Public: 08714729316442
• 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): 02/23/2021

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: 10/18/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0024788534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: 7F JR 4.0; GUIDE CATHETER: 7F JR 4.0