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	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was stuck on guidewire.The 90% stenosed target lesion was located in the main artery.A 1.25mm rotablator plus and rotawire were selected for use.During the procedure, it was noted that the burr was stuck on wire.The procedure was completed with another of the same device.There were no complications reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the rotablator rotalink plus atherectomy system.The advancer and burr catheter were returned not connected.Visual inspection of the device did not identify any damages or defects.After destructive testing was performed, inspection revealed that the coil was kinked and stretched within the sheath at the handshake connection.The burr housing was dismantled as the handshake connection was not retrievable from the burr housing.The interior components were inspected for damages or defects.Microscopic inspection of the device did not identify any damages or defects.After destructive testing was performed, inspection revealed that the sheath was worn.Product analysis confirmed the reported event, as the coil was stretched and kinked and the sheath was worn.It was considered likely that the reported events were attributable to the damaged coil.
Event or Problem Description
It was reported that the burr was stuck on guidewire.The 90% stenosed target lesion was located in the main artery.A 1.25mm rotablator plus and rotawire were selected for use.During the procedure, it was noted that the burr was stuck on wire.The procedure was completed with another of the same device.There were no complications reported, and the patient was stable post procedure.

• Brand Name: ROTALINK PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20450319
• Report Number: 2124215-2024-63363
• Device Sequence Number: 8690017
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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: 06/10/2025
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0031989807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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: Male