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

Model Number	H749236310020
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck on the guidewire.A 1.25m rotablator rotalink plus and a rotawire were selected for use.During the procedure, it was reported that the rotablator burr caught the rotawire.Replacing the rotawire did not resolve the issue, but replacing the rotablator burr did.The same rotawire was used with the second rotablator and no damages were noted on the rotawire.The rotawire and burr were removed together as one unit from the patient.The procedure was completed with another of the same device.No patient complications reported, and patient condition following procedure was stable.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection of the device found that at 28.9cm proximal from the burr tip, for a length of 1cm, the coil was stretched.As the rotawire used in the procedure was not returned, a test rotawire was used for analysis.The test rotawire was unable to be fully inserted due to resistance as the coil was stretched.
Event or Problem Description
It was reported that the burr became stuck on the guidewire.A 1.25m rotablator rotalink plus and a rotawire were selected for use.During the procedure, it was reported that the rotablator burr caught the rotawire.Replacing the rotawire did not resolve the issue, but replacing the rotablator burr did.The same rotawire was used with the second rotablator and no damages were noted on the rotawire.The rotawire and burr were removed together as one unit from the patient.The procedure was completed with another of the same device.No patient complications reported, and 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: 22669199
• Report Number: 2124215-2025-49961
• Device Sequence Number: 20734878
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)261203(10)35542425
• 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): 12/02/2025

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 Model Number: H749236310020
• Device Catalogue Number: H749236310020
• Device Lot Number: 0035542425
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 71 KG