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	02/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck on the wire.A 1.75mm rotalink plus and a rotawire and wireclip torquer were selected for use in an atherectomy procedure.The target lesion in the left anterior descending artery was severely calcified and located in moderately tortuous anatomy.During withdrawal while in dynaglide mode, the burr became stuck on the wire.The rotalink plus could not be pulled back, so both devices were removed together.The procedure was successfully completed.There were no patient complications.

• 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: 11369350
• Report Number: 2134265-2021-02065
• Device Sequence Number: 3786371
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• 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: 11/11/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0024922505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 02/23/2021
• Patient Sequence Number: 1