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

Model Number	3320
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck in the lesion.The severely stenosed target lesion was located in the severely calcified mid right coronary artery (rca).A 1.25 mm rotalink burr was selected for use.During the procedure, the burr became stuck in the lesion.The device was removed from the patient by attempting to withdraw the rotawire and rotalink burr together, without any additional intervention.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 address 1: (b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the burr became stuck in the lesion.The severely stenosed target lesion was located in the severely calcified mid right coronary artery (rca).A 1.25mm rotalink burr was selected for use.During the procedure, the burr became stuck in the lesion.The device was removed from the patient by attempting to withdraw the rotawire and rotalink burr together, without any additional intervention.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 - (b)(6).Device evaluated by manufacturer: the complaint device was received for product analysis.A visual inspection of the device found that the handshake connection was bent.It was considered likely that the reported events were attributable to the damaged handshake connection as damage to the handshake connection can result in device rotation issues and could lead to the device becoming stuck within the lesion.No other issues were identified during the product analysis.

• 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: 22002787
• Report Number: 2124215-2025-28466
• Device Sequence Number: 13042912
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: (01)08714729185864(17)250820(10)32255623
• 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): 06/23/2025

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: 08/20/2025
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0032255623
• 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: 04/27/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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
• Patient Weight: 75 KG