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

Model Number	H749236310020
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420); Failure to Advance (2524); Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr stuck in the lesion.The target lesion was located in the left anterior descending artery (lad).A 1.25mm rotablator rotalink plus was selected for percutaneous coronary intervention (pci).During the procedure, the rotalink plus was inserted but the lad vessel was too tortuous, and it was thought that the burr could be stuck in the calcium due to vessel tortuosity.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the device found that the handshake connection was bent, and the coil was stretched and kinked at the handshake connection.
Event or Problem Description
It was reported that the burr was stuck in the lesion.The target lesion was located in the left anterior descending artery (lad).A 1.25mm rotablator rotalink plus was selected for percutaneous coronary intervention (pci).During the procedure, the rotalink plus was inserted but the lad vessel was too tortuous, and it was thought that the burr could be stuck in the calcium due to vessel tortuosity.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
Event or Problem Description
It was reported that the burr stuck in the lesion.The target lesion was located in the left anterior descending artery (lad).A 1.25mm rotablator rotalink plus was selected for percutaneous coronary intervention (pci).During the procedure, the rotalink plus was inserted but the lad vessel was too tortuous, and it was thought that the burr could be stuck in the calcium due to vessel tortuosity.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.It was further reported that the 80% stenosed target lesion was located in the severely tortuous and severely calcified lad.Additionally, the burr didn't get stuck in the lesion and just fell right in.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the device found that the handshake connection was bent, and the coil was stretched and kinked at the handshake connection.

• 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: 22186161
• Report Number: 2124215-2025-36604
• Device Sequence Number: 8570597
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)261231(10)35748486
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 12/29/2025

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: 0035748486
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 08/20/2025; 12/03/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 09/08/2025; 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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: 89 YR
• Patient Sex: Male