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

Model Number	3320
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Jam (2983); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the burr became stuck in the lesion.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left circumflex artery (lcx).A 1.25mm rotalink burr was selected for use.During advancement using a pecking motion, the burr encountered significant resistance and subsequently became stuck in the lesion.The deceleration indicator was activated, and the maximum rotational speed observed was 130,000 rpm despite a set speed of 170,000 rpm.Dynaglide mode was used during removal.The catheter and guidewire were removed as one unit from the patient, and the guidewire was able to be separated from the device with no visible damage noted.The procedure was completed using an alternative device.No patient complications were reported.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).H6 - device code: updated.
Event or Problem Description
It was reported that the burr became stuck in the lesion.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left circumflex artery (lcx).A 1.25mm rotalink burr was selected for use.During advancement using a pecking motion, the burr encountered significant resistance and subsequently became stuck in the lesion.The deceleration indicator was activated, and the maximum rotational speed observed was 130,000 rpm despite a set speed of 170,000 rpm.Dynaglide mode was used during removal.The catheter and guidewire were removed as one unit from the patient, and the guidewire was able to be separated from the device with no visible damage noted.The procedure was completed using an alternative device.No patient complications were reported.
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer: the device was returned for analysis.Inspection of the device found that the majority of the coil was stretched from the handshake connection to the burr end of the device.The coil was kinked at the handshake connection.The damage present would directly impact wire advancement, removal, and rotational output.
Event or Problem Description
It was reported that the burr became stuck in the lesion.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left circumflex artery (lcx).A 1.25mm rotalink burr was selected for use.During advancement using a pecking motion, the burr encountered significant resistance and subsequently became stuck in the lesion.The deceleration indicator was activated, and the maximum rotational speed observed was 130,000 rpm despite a set speed of 170,000 rpm.Dynaglide mode was used during removal.The catheter and guidewire were removed as one unit from the patient, and the guidewire was able to be separated from the device with no visible damage noted.The procedure was completed using an alternative device.No 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: 22127533
• Report Number: 2124215-2025-34299
• Device Sequence Number: 8841629
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: (01)08714729185864(17)250513(10)31807880
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2025

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: 05/13/2025
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0031807880
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: 08/19/2025; 11/19/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 09/08/2025; 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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 Sex: Male