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

Model Number	H749236310020
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was return with an unknown rotawire (ncpr 19914431) within the device.Visual inspection of the device found that there were numerous kinks to the sheath.The rotawire was able to be removed from the device with resistance due to rotapro device damage.Microscope inspection of the device found that at 45.2cm distal from the strain relief, the sheath was torn apart.At 45.2cm distal from the strain relief, for a length of 11mm, the sheath was worn.At 49.7cm distal from the strain relief, for a length of 26mm, the sheath was worn.At 47.5cm distal from the strain relief, for a length of 16mm, the coil was stretched.
Event or Problem Description
Based on device analysis completed on 11apr2025.It was reported that the device could not cross the lesion.The 79% stenosed target lesion was located in the moderately tortuous and severely calcified mid right coronary artery.A 1.25mm rotablator rotalink plus was selected for use.During the procedure, it was noted that the device failed to passage the lesion.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the sheath was torn apart at 45.2cm 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: 21951555
• Report Number: 2124215-2025-26476
• Device Sequence Number: 21033310
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)260430(10)34138317
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 05/02/2025

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: 04/30/2026
• Device Model Number: H749236310020
• Device Catalogue Number: H749236310020
• Device Lot Number: 0034138317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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 Age: 75 YR
• Patient Sex: Male