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	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.A 2.15mm rotablator rotalink plus and a rotawire drive were selected for use.The rotablator was prepared outside the body and platformed at 180,000rpm.During insertion, it was noted that the burr was stuck with the rotawire.There was resistance encountered between the burr and rotawire.The burr and the rotawire were removed together as one unit from the patient.After removing the devices from the patient's body, damage was noted to the rotawire.The procedure was completed with replacement devices.There were no patient complications, and the patient was stable post procedure.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of the rotablator rotalink plus atherectomy device.A 3cm of the coil and sheath were returned.The remainder of the coil, sheath, and the burr were not returned.The advancer, handshake connections, sheath, and coil were visually and microscopically examined.Inspection of the device found that the sheath and coil were separated at 3cm from the burr housing strain relief and that the remainder of the device was not returned.In order to determine the functionality of the rotablator device, analysis was performed using a test rotawire as the rotawire used in the procedure was not returned.The test rotawire was unable to pass the damage to the separated coil.Inspection of the remainder of the device, revealed no damage or irregularities.
Event or Problem Description
It was reported that device entrapment occurred.A 2.15mm rotablator rotalink plus and a rotawire drive were selected for use.The rotablator was prepared outside the body and platformed at 180,000rpm.During insertion, it was noted that the burr was stuck with the rotawire.There was resistance encountered between the burr and rotawire.The burr and the rotawire were removed together as one unit from the patient.After removing the devices from the patient's body, damage was noted to the rotawire.The procedure was completed with replacement devices.There were no patient complications, and the patient was stable post procedure.

• Brand Name: ROTALINK PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15834796
• Report Number: 2124215-2022-48141
• Device Sequence Number: 5426896
• Product Code: MCX
• UDI-Device Identifier: 08714729316473
• UDI-Public: 08714729316473
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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: 04/05/2024
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0029351355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown