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

Model Number	H749236310020
Medical Device Problem Codes	Fluid/Blood Leak (1250); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that water leakage was observed at the middle of the shaft.A 1.25mm rotalink? plus was selected for treatment of the severely calcified left anterior descending artery.During preparation, water leakage was observed at the middle section of the shaft instead of the normal drip at the rear end of the device.The guidewire crossed the tip of the device but could not smoothly exit the tail end.Multiple attempts were unsuccessful, and the procedure was successfully completed after replacing the burr.There were no patient complications and the patient condition following procedure was stable.
Additional Manufacturer Narrative
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 fluid leak and difficult/unable to load onto guidewire 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: a thorough review of the reported complaint and the corresponding labeling, the reported allegation is attributable to a device damage or defect, but the nature of the damage or defect could not be determined using the information available.The investigation conclusion code of cause linked to device but unable to trace more specifically was selected.
Event or Problem Description
It was reported that water leakage was observed at the middle of the shaft.A 1.25mm rotalink plus was selected for treatment of the severely calcified left anterior descending artery.During preparation, water leakage was observed at the middle section of the shaft instead of the normal drip at the rear end of the device.The guidewire crossed the tip of the device but could not smoothly exit the tail end.Multiple attempts were unsuccessful, and the procedure was successfully completed after replacing the burr.There were no patient complications and the patient condition following procedure was stable.

• 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: 24554633
• Report Number: 2124215-2026-13072
• Device Sequence Number: 8859933
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)270429(10)36631627
• 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): 04/09/2026

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: H749236310020
• Device Catalogue Number: H749236310020
• Device Lot Number: 0036631627
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/09/2026
• Date Device Manufactured: 05/29/2025
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 70 KG