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

Model Number	H80222782001A0
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that a brake malfunction occurred.The target lesion was located in the coronary artery.A rotalink advancer was selected for percutaneous coronary angioplasty.The guidewire failed to lock properly and the device could not be advanced.The black button on the guidewire clamp was not functional and the guidewire failed to move after initiating the brake defeat.The procedure was completed with another advancer.There were no patient complications reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter phone:(b)(6).Investigation results: device analysis findings: device evaluated by manufacturer: the device was returned for analysis.A visual inspection of the device found that the handshake connection was bent severely which would directly impact device rotation.The brake defeat button was partially returned and was dismantled/loose from the advancer.As the rotawire used in the procedure was not returned, a test rotawire was used for analysis.During analysis, the test rotawire was able to be fully inserted and removed from the device with minimal resistance due to the bend in the handshake connection.When the advancer was connected to the rotablator console and the foot pedal was pressed, the device stalled and did not run.It was considered likely that the stall during analysis was attributable to the bent handshake connection.Despite device stall during analysis, and with the brake defeat button detached and partially returned, the shuttle brake component was exposed and able to be pressed to continue brake testing, thus, the brake was able to engage and disengage properly with the test wire without issue or resistance.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 if completed: a risk review was completed and confirmed that the events of difficult or unable to engage brake and system - damaged brake defeat issue were 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, and successful brake testing, the investigation conclusion code of no problem detected, was selected for this complaint.The reported brake button damage was able to be confirmed from analysis as the device returned with a portion of the brake defeat button which returned separately from the advancer body.During product analysis, fails to confirm the reported brake failure to lock on wire as the brake was able to engage and disengage with the wire without issue or resistance during device testing.The reported events do not indicate any damages or defects to the device during unpackaging, it was considered likely that the reported brake button damage and the damages present to the device occurred due to handling of the device which can include device interaction during use.Therefore, the cause code unintended use error caused or contributed to event was selected for the confirmed device damages and the reported brake button damage.
Event or Problem Description
It was reported that a brake malfunction occurred.The target lesion was located in the coronary artery.A rotalink advancer was selected for percutaneous coronary angioplasty.During the procedure, it was noted that the advancer could not advance because the guidewire failed to lock properly in normal mode.Additionally, the black button on the guidewire clamp was non functional, showing no movement after initiating the brake defeat button.The procedure was completed with another of the same device.There were no patient 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: 23872904
• Report Number: 2124215-2025-92462
• Device Sequence Number: 4619181
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: (01)08714729317739(17)270407(10)36245273
• 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): 04/20/2026

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: 0036245273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 53 KG