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

Model Number	3320
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a burr fracture occurred.The 60mm x 3.5mm in diameter, 95% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 1.50mm rotalink burr was selected for use.During the procedure, after the advancer was connected, the wire could not come out from the burr.It was then noted that the burr was fractured 5cm from the connection of the advancer upon opening.The procedure was completed with a different device.No complications were reported, and patient was stable post procedure.
Additional Manufacturer Narrative
E1-(b)(6).
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection of the device found that the coil was kinked and stretched at the handshake connection.Microscope inspection of the device found no damage or irregularity.
Event or Problem Description
It was reported that a burr fracture occurred.The 60mm x 3.5mm in diameter, 95% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 1.50mm rotalink burr was selected for use.During the procedure, after the advancer was connected, the wire could not come out from the burr.It was then noted that the burr was fractured 5cm from the connection of the advancer upon opening.The procedure was completed with a different device.No complications were reported, and patient was stable post 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20791989
• Report Number: 2124215-2024-72478
• Device Sequence Number: 12451260
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: 08714729185857
• 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): 01/09/2025

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: 06/07/2026
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0034193157
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 82 KG