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	11/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck on the rotawire.A percutaneous coronary intervention was being performed on a severely calcified lesion.This 2.25mm rotablator plus along with a rotawire drive were selected.During the procedure, the rotalink plus burr and rotawire drive became locked up and could not be removed.Therefore the rotalink plus and rotawire drive were removed from the patient as one unit.The procedure was successfully completed.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of the rotablator rotalink atherectomy device.The rotawire drive used in the procedure was returned through related.The advancer, handshake connections, burr housing, coil, sheath, burr, and annulus were visually examined.Inspection of the device did not identify any damages or defects.Functional testing was performed by attempting to advance the returned rotawire through the rotablator device.The returned rotawire was able to be advanced and removed from the rotablator device with no resistance or issues.
Event or Problem Description
It was reported that the burr became stuck on the rotawire.A percutaneous coronary intervention was being performed on a severely calcified lesion.This 2.25mm rotablator plus along with a rotawire drive were selected.During the procedure, the rotalink plus burr and rotawire drive became locked up and could not be removed.Therefore the rotalink plus and rotawire drive were removed from the patient as one unit.The procedure was successfully completed.

• 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 CORPORATION; model farm road cork; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12868434
• Report Number: 2134265-2021-14798
• Device Sequence Number: 3607863
• Product Code: MCX
• UDI-Device Identifier: 08714729228394
• UDI-Public: 08714729228394
• 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): 12/20/2021

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: 10/26/2022
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0026420799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2020
• 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