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

Model Number	3320
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420); Mechanical Jam (2983); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that burr got stuck in the lesion.The 80% stenosed target lesion was located in the severely tortuous and moderately calcified right coronary artery.A 1.25 mm rotalink burr was selected for use.During the procedure, the device was advance in a set speed of 160,000 rpm with a maximum speed reached up to 140,000 rpm.Upon advancement, a significant resistance encountered between the burr and guidewire, and the burr was noted to be stuck in lesion.The catheter and guidewire were removed as one unit.The procedure was completed successfully using an alternative method.No patient complications were reported.
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that burr got stuck in the lesion.The 80% stenosed target lesion was located in the severely tortuous and moderately calcified right coronary artery.A 1.25 mm rotalink burr was selected for use.During the procedure, the device was advance in a set speed of 160,000 rpm with a maximum speed reached up to 140,000 rpm.Upon advancement, a significant resistance encountered between the burr and guidewire, and the burr was noted to be stuck in lesion.The catheter and guidewire were removed as one unit.The procedure was completed successfully using an alternative method.No patient complications were reported.
Event or Problem Description
It was reported that burr got stuck in the lesion.The 80% stenosed target lesion was located in the severely tortuous and moderately calcified right coronary artery.A 1.25 mm rotalink burr was selected for use.During the procedure, the device was advance in a set speed of 160,000 rpm with a maximum speed reached up to 140,000 rpm.Upon advancement, a significant resistance encountered between the burr and guidewire, and the burr was noted to be stuck in lesion.The catheter and guidewire were removed as one unit.The procedure was completed successfully using an alternative method.No patient complications were reported.
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).H6 device code: updated.Device evaluated by manufacturer: the device was returned for analysis.Inspection of the device found that the returned rotawire was not visible at the handshake connection but was visible at the burr end.The wire was found to be frozen as majority of the coil was stretched from the handshake connection to the burr end of the device indicating tensile force was applied.The burr housing was dismantled to view inner components to which the handshake connection was bent within the sheath upon device return and was unable to be retrieved.The annulus of the burr was found to be damaged.A photo of the product packaging to the reported lot batch was attached to the complaint record, but no evidence of the reported events was present within the attached photo.

• 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: 22136599
• Report Number: 2124215-2025-35106
• Device Sequence Number: 7343382
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: (01)08714729185864(17)250521(10)31862284
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2025

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: 05/21/2025
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0031862284
• 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; 11/26/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 09/15/2025; 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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 Sex: Male