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

Model Number	H80222782001A0
Medical Device Problem Codes	Nonstandard Device (1420); Material Integrity Problem (2978); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1 initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the brake defeat malfunctioned.The target lesion was located in the calcified left anterior descending artery.A rotalink advancer with tubular drive shaft was selected for treatment.During preparation, in normal mode, it was noted that the brake defeat malfunctioned and the device did not work.The procedure was completed with another of same device.There were no complications reported, and the patient was stable post procedure.
Event or Problem Description
It was reported that the brake defeat malfunctioned.The target lesion was located in the calcified left anterior descending artery.A rotalink advancer with tubular drive shaft was selected for treatment.During preparation, in normal mode, it was noted that the brake defeat button malfunctioned and the device did not work.During rotation, wire movement was experienced.The procedure was completed with another of same device.There were no complications reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1 initial reporter phone: (b)(6).H6 device code: updated.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1 initial reporter phone: (b)(6).H6 device code: updated.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection found that the brake defeat button was unseated.Analysis was performed using a test rotawire as the rotawire used during the procedure was not returned.After the rotawire was inserted through the device, the advancer was connected to the rotablator console, and the foot pedal was pressed, the brake activated and held the rotawire in place during normal and dynaglide modes.The functionality of the brake defeat button could not be assessed due to the unseated button.Photos of were attached to the complaint record showing the device and the unseated brake defeat button in accordance with findings during analysis.
Event or Problem Description
It was reported that the brake defeat malfunctioned.The target lesion was located in the calcified left anterior descending artery.A rotalink advancer with tubular drive shaft was selected for treatment.During preparation, in normal mode, it was noted that the brake defeat button malfunctioned and the device did not work.During rotation, wire movement was experienced.The procedure was completed with another of same device.There were no complications reported, and the patient was stable post procedure.

• Brand Name: ROTALINK? ADVANCER
• 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: 23686482
• Report Number: 2124215-2025-85959
• Device Sequence Number: 9753650
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: (01)08714729317739(17)270113(10)35617020
• 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,Followup
• Report Date (Section B): 02/02/2026

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 Model Number: H80222782001A0
• Device Catalogue Number: H80222782001A0
• Device Lot Number: 0035617020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 01/08/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/26/2025; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 60 KG