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

Model Number	H80222782001A0
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that failure to lock wire occurred.The 90% stenosed target lesion with 10 mm in length and 2.67 mm in diameter, was located in the mildly tortuous and severely calcified left circumflex.A rotablator was selected for use.During insertion into the patient's body in dynaglide mode, it was noted that the guidewire started rotating at the rear end of the advancer.Multiple subsequent tests demonstrated the same rotation issue.Per the physician, guidewire movement occurred during rotation without initiating the brake defeat, indicating a malfunction in the mechanism which is designed to lock the guidewire.The device was simply removed and the procedure was competed with another of the same device.There were no patient complications; the patient remained stable.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was completed and confirmed that the event of brake failure to lock on wire was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the dhr and reported complaint, the most probable cause for this complaint was considered adverse event related to procedure as the reported events do not indicate any device damages or brake failures during unpackaging, preparation, or testing.
Event or Problem Description
It was reported that failure to lock wire occurred.The 90% stenosed target lesion with 10mm in length and 2.67mm in diameter, was located in the mildly tortuous and severely calcified left circumflex.A rotablator was selected for use.During insertion into the patient's body in dynaglide mode, it was noted that the guidewire started rotating at the rear end of the advancer.Multiple subsequent tests demonstrated the same rotation issue.Per the physician, guidewire movement occurred during rotation without initiating the brake defeat indicating a malfunction in the mechanism which is designed to lock the guidewire.The device was simply removed and the procedure was competed with another of the same device.There were no patient complications, the patient remained stable.

• 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: 24512878
• Report Number: 2124215-2026-11986
• Device Sequence Number: 10227464
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: (01)08714729317739(17)270725(10)37057728
• 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): 04/08/2026

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: 0037057728
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/08/2026
• Date Device Manufactured: 07/25/2025
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 60 KG