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

Model Number	H749236310030
Medical Device Problem Codes	Entrapment of Device (1212); Gas/Air Leak (2946); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck with the wire.A 1.50 mm rotablator rotalink plus and a 330 cm gw (1pk) flop rotawire were selected for use.During device preparation and execution of the draw test, the console registered a sudden drop in rpm, accompanied by an audible gas leak from the device.A second test was performed, with the same gas leak noted.When attempting to disengage the rotalink burr from the rotawire, the burr became lodged and could not be separated.As a result, both the burr and the guidewire were removed simultaneously.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable after the procedure.
Event or Problem Description
It was reported that the burr became stuck with the wire.A 1.50mm rotablator rotalink plus and a 330cm gw(1pk) flop rotawire were selected for use.During device preparation and execution of the draw test, the console registered a sudden drop in rpm, accompanied by an audible gas leak from the device.A second test was performed, with the same gas leak noted.When attempting to disengage the rotalink burr from the rotawire, the burr became lodged and could not be separated.As a result, both the burr and the guidewire were removed simultaneously.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable after the procedure.
Additional Manufacturer Narrative
H6: device codes: corrected.
Event or Problem Description
It was reported that the burr became stuck with the wire.A 1.50mm rotablator rotalink plus and a 330cm gw(1pk) flop rotawire were selected for use.During device preparation and execution of the draw test, the console registered a sudden drop in rpm, accompanied by an audible gas leak from the device.A second test was performed, with the same gas leak noted.When attempting to disengage the rotalink burr from the rotawire, the burr became lodged and could not be separated.As a result, both the burr and the guidewire were removed simultaneously.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable after 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 ; 7634941632
• MDR Report Key: 22978310
• Report Number: 2124215-2025-59676
• Device Sequence Number: 13148861
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: (01)08714729228363(17)251212(10)33198556
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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,Followup
• Report Date (Section B): 12/31/2025

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: 12/12/2025
• Device Model Number: H749236310030
• Device Catalogue Number: H749236310030
• Device Lot Number: 0033198556
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 09/18/2025; 12/05/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/15/2025; 12/31/2025
• Date Device Manufactured: 01/12/2024
• 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: 58 YR
• Patient Sex: Male