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	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was stuck.The 85% stenosed, 60 mm x 3.0 mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00 mm rotalink burr was selected for use.During the procedure, it was noted that the device was stuck.The procedure was completed with another of the same device.No patient complications reported and the patient was stable post procedure.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by manufacturer.Inspection of the device found that the coil was kinked and stretched at the handshake connection.A test advancer was used for analysis as the advancer used in the procedure was not returned for analysis.After the burr catheter was connected to the advancer and the advancer was connected to the rotablator console, the foot pedal was pressed to start rotation.The test advancer rotated momentarily but stalled due to the damaged coil of the returned burr catheter.
Event or Problem Description
It was reported that the device was stuck.The 85% stenosed, 60mm x 3.00mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm rotalink burr was selected for use.During the procedure, it was noted that the device was stuck.The procedure was completed with another of the same device.No patient complications reported and the patient was stable post procedure.It was further reported that the tip of the burr was stuck and the device was removed together with the whole system.

• 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: 20982819
• Report Number: 2124215-2024-79341
• Device Sequence Number: 18397846
• Product Code: MCX
• UDI-Device Identifier: 08714729126881
• UDI-Public: 08714729126881
• 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): 01/23/2025

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: 02/06/2026
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0033373090
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 55 KG