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

Model Number	3241
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual examination of the device found that a portion of a rotawire was stuck within the distal end of the burr and could not be removed.In order to test the functionality of the device, a test rotawire was used for analysis.During testing, the rotawire was able to be inserted through the advancer from the handshake connection.The rotawire could be inserted through the proximal end of the burr catheter up to the stuck rotawire portion with no resistance or issues.
Event or Problem Description
It was reported that the burr could not be loaded on the guide wire.A 1.75mm rotablator rotalink plus and rotawire were selected for rotational atherectomy.During the procedure, it was noted that the burr could not be loaded on the guide wire.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed that a portion of a rotawire was stuck within the distal end of the burr and could not be removed.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual examination of the device found that a portion of a rotawire was stuck within the distal end of the burr and could not be removed.In order to test the functionality of the device, a test rotawire was used for analysis.During testing, the rotawire was able to be inserted through the advancer from the handshake connection.The rotawire could be inserted through the proximal end of the burr catheter up to the stuck rotawire portion with no resistance or issues.
Event or Problem Description
It was reported that the burr could not be loaded on the guide wire.A 1.75mm rotablator rotalink plus and rotawire were selected for rotational atherectomy.During the procedure, it was noted that the burr could not be loaded on the guide wire.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed that a portion of a rotawire was stuck within the distal end of the burr and could not be removed.

• 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 CORK LIMITED; 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: 23234499
• Report Number: 2124215-2025-69771
• Device Sequence Number: 15896296
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: 05/07/2026
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0034183665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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: 53 YR
• Patient Sex: Male