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

Model Number	H749236310030
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that a device detachment occurred.The stenosed target lesion was located in the right coronary artery.A 1.50 mm rotablator plus was selected for use.During the procedure, rotablation was performed for plaque modification.Rotalink plus was taken for preparation but while performing draw test on dynaglide mode, burr driveshaft detached from the protective sheath.The device was then removed from the wire, and the procedure was completed with another of the same device.There were no patient complications were reported post procedure.
Additional Manufacturer Narrative
Device analysis findings: device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection of the device found the sheath was kinked at the strain relief.At the strain relief, 12cm distal from the handshake connection, the coil was stretched and detached.No other issues were identified during the product analysis.Media review: photo media provided depicted a portion of the burr catheter with a detached coil present confirming the reported events.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.Investigation conclusion: based on a thorough review, the most probable cause for this complaint was considered adverse event related to procedure.E1.Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that a device detachment occurred.The stenosed target lesion was located in the right coronary artery.A 1.50 mm rotablator plus was selected for use.During the procedure, rotablation was performed for plaque modification.Rotalink plus was taken for preparation but while performing draw test on dynaglide mode, burr driveshaft detached from the protective sheath.The device was then removed from the wire, and the procedure was completed with another of the same device.There were no patient complications were reported post 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 ; 7634941632
• MDR Report Key: 23370364
• Report Number: 2124215-2025-75616
• Device Sequence Number: 12990840
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: (01)08714729228363(17)270419(10)36554163
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 04/28/2026

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: H749236310030
• Device Catalogue Number: H749236310030
• Device Lot Number: 0036554163
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 7F JR 3; 7F JR 3; RUNTHROUGH NS WIRE; RUNTHROUGH NS WIRE
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 58 KG