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

Model Number	3320
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was stuck in the lesion.The 18mm x 3.5 in diameter, 95% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).A 1.75mm rotalink burr was selected for use.During the procedure, it was noted that the device got stuck in the lesion.The device was removed from the patient together with the entire system.The procedure was completed with another of the same device.No patient complications were reported, and the patient was stable after the procedure.
Additional Manufacturer Narrative
E1- initial reporter facility name, address, and phone: (b)(6).
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer: the rotalink burr device was received for product analysis.A visual inspection of the device found that the handshake connection was not visible nor retrievable.Upon dismantling the burr housing, the handshake connection was able to be retrieved with resistance.The coil was found to be kinked and stretched at the handshake connection indicating the cause of the resistance while retrieving during analysis.The damage present directly impacts device rotation.Photo media provided depicted a portion of the outer box product packaging; however, no evidence of the reported event could be confirmed with the media provided.
Event or Problem Description
It was reported that the device was stuck in the lesion.The 18mm x 3.5 in diameter, 95% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).A 1.75mm rotalink burr was selected for use.During the procedure, it was noted that the device got stuck in the lesion.The device was removed from the patient together with the entire system.The procedure was completed with another of the same device.No patient complications were reported, and the patient was stable after the procedure.

• Brand Name: ROTALINK BURR
• 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: 22487699
• Report Number: 2124215-2025-44967
• Device Sequence Number: 12748372
• Product Code: MCX
• UDI-Device Identifier: 08714729185840
• UDI-Public: (01)08714729185840(17)260917(10)34868897
• 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): 08/26/2025

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: 09/17/2026
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0034868897
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 86 KG