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	Cardiac Arrest (1762)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that burr was stuck and cardiac arrest occurred.The target lesion was located in the left main trunk.A rotablator plus 1.50mm was selected for use.The patient presented in heart failure with severe stenosis obstructing blood flow.During the procedure, the burr was jammed and stuck and the patient went into cardiac arrest.Rotational atherectomy was not completed.It was further reported that the burr was successfully removed.The patient condition remains stable following the cardiac arrest.
Additional Manufacturer Narrative
B2 outcomes attrib to adv event: corrected.A4 weight: 82.5 kg.E1 initial reporter address 1: (b)(6).E1 initial reporter phone: (b)(6).With all the available information, boston scientific concludes: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.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 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 device events and following patient events occurred due to factors encountered during the procedure.

• 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 ; +1(612)875-7234
• MDR Report Key: 50698115
• Report Number: 2124215-2026-48258
• Device Sequence Number: 18545424
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• 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): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H749236310030
• Device Catalogue Number: H749236310030
• Device Lot Number: 0038585040
• 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: 08/14/2026
• Initial Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 02/12/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male