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

Model Number	H80222782001A0
Medical Device Problem Codes	Entrapment of Device (1212); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck in the lesion.A rotalink advancer w/tubular drive shaft was selected for use.During the procedure, it was noted that the burr became stuck.The physician urgently cut off the burr and the procedure was completed with another of the same device.The patient was stable following the procedure.
Additional Manufacturer Narrative
E.1.: initial reporter address 1 and phone: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
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 burr became stuck in the lesion.A rotalink advancer w/tubular drive shaft was selected for use.During the procedure, it was noted that the burr got stuck, which was a critical situation.The physician urgently cut off the burr.The procedure was completed with another of the same device.No complications were reported and the patient was stable following the procedure.It was further reported that the 95% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery (rca).The device stalled prior to the 1.5 mm burr becoming stuck.There was no significant resistance between the burr and the rotawire.

• 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: 23315767
• Report Number: 2124215-2025-72065
• Device Sequence Number: 4989160
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: (01)08714729317739(17)270508(10)36470200
• 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
• Report Date (Section B): 11/14/2025

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 Model Number: H80222782001A0
• Device Catalogue Number: H80222782001A0
• Device Lot Number: 0036470200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 10/19/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/14/2025
• Date Device Manufactured: 05/08/2025
• 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 Sex: Unknown