MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RotaLink? Advancer; catheter, coronary, atherectomy

Model Number	H80222782001A0
Medical Device Problem Codes	Failure to Advance (2524); Output Problem (3005); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that unstable speed occurred.The stenosed target lesion was located in the left anterior descending artery.A rotalink advancer was selected for use.During test outside the patient, everything was normal.However, during the procedure the burr could not be pushed into the guiding catheter, resulting in stalling and stuttering.The device exceeded the set operational speed of 150k rpm as it reached 160k rpm during normal mode.The procedure was completed with another of the same device.There were no patient complications reported post procedure.
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).Device analysis results.Device technical analysis: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history review: it was confirmed that this device met manufacturing specification prior to distribution and there are 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 performed and confirmed that the event 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 reported complaint, the most probable cause for this complaint was considered adverse event related to procedure.The reported event indicated that during the procedure the burr could not be pushed into the guiding catheter, resulting in stalling and stuttering.The device was not returned for analysis, and the reported events could not be confirmed using the available information.A review of the device history record "[dhr]" indicates that the device was manufactured per specification.The instructions for use include testing of the device before usage within the body and state that use of the device is to be discontinued if evidence of a failure or damage is present.As the reported events do not indicate any device damages or failures during unpackaging, preparation, or testing, it was considered likely that the reported events were attributable to factors encountered during the 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 ; +1(612)875-7234
• MDR Report Key: 50669980
• Report Number: 2124215-2026-47782
• Device Sequence Number: 9512532
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: (01)08714729317739(17)260702(10)34355347
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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 Expiration Date: 07/02/2026
• Device Model Number: H80222782001A0
• Device Catalogue Number: H80222782001A0
• Device Lot Number: 0034355347
• 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: 08/11/2026
• Initial Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 07/02/2024
• 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: 145 LB