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	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck on the rotawire.The target lesion was located in the left coronary artery.A 1.50mm rotalink burr and a rotawire were selected for percutaneous coronary intervention (pci).During the procedure, the burr was on the rotawire inside the patient.The procedure was completed with another rotalink burr and rotawire.No patient complications were reported, and the patient was stable post procedure.
Event or Problem Description
It was reported that the burr became stuck on the rotawire.The target lesion was located in the left coronary artery.A 1.50mm rotalink burr and a rotawire were selected for percutaneous coronary intervention (pci).During the procedure, the burr was on the rotawire inside the patient.The procedure was completed with another rotalink burr and rotawire.No patient complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the rotalink burr atherectomy catheter device was returned for analysis.Visual inspection of the device found that the handshake connection was separated and the coil was stretched up to approximately 42.5cm from the proximal end.Product analysis confirmed the reported events, as the coil was stretched and the handshake connection was separated.Damages to the coil and handshake connection can result in both rotowire insertion and removal issues and was considered a likely cause for the reported stuck rotowire.

• 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: 22073681
• Report Number: 2124215-2025-31851
• Device Sequence Number: 8766413
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: (01)08714729185857(17)260731(10)34544369
• 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): 10/29/2025

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 Expiration Date: 07/31/2026
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0034544369
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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: 69 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG