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

Model Number	H749236310030
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck with the guidewire.The target lesion was located in the severely calcified left anterior descending (lad) artery.A 1.50mm rotablator rotalink plus and rotawire-ic were selected for use.During the procedure, the physician prepared for rotational ablation and used the guidewire for calcification treatment.After exchanging the rotational ablation guidewire in the left anterior descending (lad) artery, the guidewire was connected to the burr.The guidewire crossed the tail end of the burr and was slowly inserted into the blood vessel to approach the calcification area.However, during the rotational ablation process, it was found that the guidewire was stuck to the burr and could not be pushed forward or backward.After trying several times, it was not possible to push it.Therefore, the burr and guidewire were replaced, and the procedure was completed using another of the same device.There were no patient complications, and the patient was stable post procedure.
Additional Manufacturer Narrative
A - patient identifier: (b)(6).E1 - initial reporter 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.

• 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: 25001709
• Report Number: 2124215-2026-22595
• Device Sequence Number: 9774109
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: (01)08714729228363(17)270902(10)37606328
• 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): 06/04/2026

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: H749236310030
• Device Catalogue Number: H749236310030
• Device Lot Number: 0037606328
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 06/04/2026
• Date Device Manufactured: 10/02/2025
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 85 KG