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

Model Number	3320
Medical Device Problem Codes	Nonstandard Device (1420); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that device detachment occurred.The target lesion was located in the coronary artery.A 1.25mm rotalink burr was selected for use.During the procedure, the burr catheter was fractured.The device was completely removed from the body of the patient, and the procedure was completed with another of the same device.There were no patient complications, and patient is stable and in good condition after the procedure.
Event or Problem Description
It was reported that device detachment occurred.The target lesion was located in the coronary artery.A 1.25mm rotalink burr was selected for use.During the procedure, the burr catheter was fractured.The device was completely removed from the body of the patient, and the procedure was completed with another of the same device.There were no patient complications, and patient is stable and in good condition after the procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection of the device found that there were copious amounts of blood present within the sheath upon device return.The coil was found kinked and stretched at the handshake connection.The handshake connection was not visible upon device return but was able to be retrieved from the housing.No other issues were identified during the product analysis.E1 - initial reporter phone: (b)(6).

• 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: 22834527
• Report Number: 2124215-2025-57250
• Device Sequence Number: 11903324
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: (01)08714729185864(17)260808(10)34598671
• 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): 02/05/2026

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: 08/08/2026
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0034598671
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 74 KG