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	11/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the rotablator rotalink plus atherectomy device.The burr catheter was received attached to the advancer unit.A rotowire returned within the device.Visual inspection of the device identified that the returned wire was froze within the burr catheter and was not removable due to coil damage and wire damage present.The majority of the wire was returned out of the burr end of the device, indicating a possible attempt of wire removal.There were numerous sheath kinks and bends.Microscope inspection of the device identified that the sheath was worn 29.5cm in length, 46cm proximal from the distal end of the sheath and 8.2cm in length, 1.1cm proximal from distal end of the sheath.The coil was found to be stretched from the handshake connection to 6.2 cm proximal from the burr end of the device.Inspection of the remainder of the device, revealed no damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 24feb2025.It was reported that the burr could not cross lesion.The target lesion was located in the calcified left anterior descending artery.A 1.25mm rotalink plus and rotawire were selected for percutaneous coronary intervention (pci).It was noted that the burr could not cross the lesion.The procedure was completed with another device.There was no patient complications reported, and patient was good post procedure.However, device analysis revealed that the wire was froze within the burr catheter.

• 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: 21679140
• Report Number: 2124215-2025-14232
• Device Sequence Number: 18195324
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• 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): 03/24/2025

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: 12/31/2025
• Device Model Number: H749236310020
• Device Catalogue Number: H749236310020
• Device Lot Number: 0033326786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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: 67 YR
• Patient Sex: Male