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

Model Number	H749236310020
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned product consisted of the rotablator rotalink plus atherectomy device.The distal end of the burr catheter including the burr was not returned for further analysis.Inspection of the device found that for a length of 8mm distal from the strain relief, the sheath was worn and torn.The coil was detached and stretched at 1.5cm distal from the strain relief.
Event or Problem Description
Reportable based on device analysis completed on 18jul2025.It was reported that the burr failed to advance the lesion.A 1.25mm rotablator rotalink plus was selected for use in the right coronary artery.During the procedure, the doctor was trying to burr the calcified lesion in rca but somehow the rotablation was not impactful.The doctor then decided to go with ivl and completed the procedure.No patient complications reported.However, device analysis revealed that the sheath was worn and torn.The coil was detached at 1.5cm distal from the strain relief.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22787049
• Report Number: 2124215-2025-53995
• Device Sequence Number: 8127769
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)250626(10)32100549
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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: 06/26/2025
• Device Model Number: H749236310020
• Device Catalogue Number: H749236310020
• Device Lot Number: 0032100549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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: Unknown