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

Model Number	3320
Medical Device Problem Codes	Entrapment of Device (1212); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the burr was stuck in the lesion.The chronic total occlusion (cto) target lesion was located in the mildly tortuous and severely calcified right coronary artery (rca).A 1.25mm rotablator and rotawire were selected for treatment.During the procedure, it was noted that the advancer leaked air, the burr was stalled and became stuck in the lesion.The target speed was 180,000 rpm and the actual speed was 160,000 rpm.The burr was completely removed from the patient's body with the rotawire.The procedure was completed with another of the same device.No complications were reported and the patient was stable following the procedure.
Additional Manufacturer Narrative
(b)(6).A2: age at time of event: corrected.A2: unit of measure - age: corrected.A3a: sex: corrected.A3b: gender: corrected.A4: weight: corrected.A4: unit of measure - weight: corrected.
Event or Problem Description
It was reported that the burr was stuck in the lesion.The chronic total occlusion (cto) target lesion was located in the mildly tortuous and severely calcified right coronary artery (rca).A 1.25mm rotablator and rotawire were selected for treatment.During the procedure, it was noted that the advancer leaked air, the burr was stalled and became stuck in the lesion.The target speed was 180,000 rpm and the actual speed was 160,000 rpm.The burr was completely removed from the patient's body with the rotawire.The procedure was completed with another of the same device.No complications were reported and the patient was stable following the 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 CORK LIMITED; 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: 22288627
• Report Number: 2124215-2025-38324
• Device Sequence Number: 8310175
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: (01)08714729185864(17)250820(10)32255623
• 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): 07/30/2025

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: 08/20/2025
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0032255623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/30/2025
• Date Device Manufactured: 08/21/2023
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 78 KG