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

Model Number	3320
Medical Device Problem Codes	Entrapment of Device (1212); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck on the wire.A 2.00mm rotalink burr, a rotalink advancer, and a rotawire and wireclip torquer were selected for use in a percutaneous coronary intervention to treat coronary artery disease.After wiring the vessel with a conventional workhorse wire and then exchanging for a rotawire, a rotalink burr was advanced into the proximal right coronary artery using dynaglide mode.Before ablation began in the target lesion, an unusual constant noise was heard from the console.The physician was under the impression that the burr was not rotating.Since the cause of the problem could not be identified, the rotalink burr was removed, but it was stuck on the rotawire.When withdrawing the rotalink burr, the rotawire came back as well despite being secured with the brake.The rotawire was noted as not kinked, initially.Ultimately, the rotalink burr, the rotalink advancer, and the rotawire were all exchanged for new devices of the same type.The procedure was successfully completed.No patient complications were reported.
Event or Problem Description
It was reported that the burr became stuck on the wire.A 2.00mm rotalink burr, a rotalink advancer, and a rotawire and wireclip torquer were selected for use in a percutaneous coronary intervention to treat coronary artery disease.After wiring the vessel with a conventional workhorse wire and then exchanging for a rotawire, a rotalink burr was advanced into the proximal right coronary artery using dynaglide mode.Before ablation began in the target lesion, an unusual constant noise was heard from the console.The physician was under the impression that the burr was not rotating.Since the cause of the problem could not be identified, the rotalink burr was removed, but it was stuck on the rotawire.When withdrawing the rotalink burr, the rotawire came back as well despite being secured with the brake.Ultimately, the rotalink burr, the rotalink advancer, and the rotawire were all exchanged for new devices of the same type.The rotawire was noted as not kinked, initially.The procedure was successfully completed.No patient complications were reported.It was further clarified that there was no issue with the guidewire brake, and the rotawire was not kinked.When attempting to remove the rotalink burr, it was noted that the wire was fixed to the burr.Therefore, the burr and wire were pulled back together.

• Brand Name: ROTALINK BURR
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11483459
• Report Number: 2134265-2021-03311
• Device Sequence Number: 3412338
• Product Code: MCX
• UDI-Device Identifier: 08714729126881
• UDI-Public: 08714729126881
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 04/14/2021

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: 09/29/2022
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0026267992
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/14/2021
• Patient Sequence Number: 1