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

Model Number	3320
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the burr became stuck in the lesion, dissection occurred, and surgery was required.The patient was diagnosed with unstable angina and coronary artery disease and underwent percutaneous transluminal coronary angioplasty (ptca) and percutaneous coronary rotational atherectomy.The target lesion was located in the left anterior descending (lad) artery.A 1.75mm rotalink burr was selected for use.During the procedure, the burr stalled when crossing a calcified area in the middle segment of the lad.Upon retraction, the burr became stuck at the lesion and could not be started and removed.Angiography showed that forward blood flow in the lad was timi grade 3 with no chest pain symptoms.The catheter of the burr was cut in a failed attempt to remove the burr with the support of a guidezilla device.Right femoral artery access was obtained, and a 6f arterial sheath was inserted.A non-boston scientific guiding catheter was then delivered to the opening of the left coronary artery (lca).However, it was difficult to cross the lesion site with two different non-boston scientific guidewires.A 1.2mm x 8mm and a 1.5mm x 15mm non-boston scientific balloons were then used but could not dislodge the burr.As a result, the interventional procedure was unsuccessful, and the treatment approach was changed to an open surgical procedure.The patient was transferred to the cardiac procedure department for surgical intervention.No further patient complications were reported.

• 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: 22677414
• Report Number: 2124215-2025-46861
• Device Sequence Number: 21200446
• Product Code: MCX
• UDI-Device Identifier: 08714729185840
• UDI-Public: (01)08714729185840(17)260114(10)33211525
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2026
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0033211525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 07/31/2025
• Date Device Manufactured: 01/15/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 62 YR
• Patient Sex: Male