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

Model Number	3320
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a burr break occurred.A 2.25 mm rotalink burr was selected for use in the left anterior descending (lad) artery.During the procedure, the end of the burr broke and the device completely removed from the patient in one piece.The procedure was completed using another of the rotalink burr device.No complications were reported, and patient is stable post 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 a burr break occurred.A 2.25mm rotalink burr was selected for use in the left anterior descending (lad) artery.During the procedure, the end of the burr broke and the device completely removed from the patient in one piece.The procedure was completed using another of the rotalink burr device.No complications were reported, and patient is stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).Device evaluated by manufacturer: the rotalink burr device was received for analysis.A visual inspection of the device found no damage or irregularity.Inspection of the device after the burr housing was dismantled, it was found that the handshake connection was in good condition and was able to be retrieved from the sheath as the burr was extended too far forward.Microscopic inspection of the device found no damage or irregularity.Inspection of the remainder of the device, revealed no other damage or irregularities.

• 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: 22039646
• Report Number: 2124215-2025-29402
• Device Sequence Number: 8782227
• Product Code: MCX
• UDI-Device Identifier: 08714729185819
• UDI-Public: (01)08714729185819(17)261017(10)35086287
• 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): 08/11/2025

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 Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0035086287
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 79 KG