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

Model Number	3320
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was stuck on wire.The 15 mm long and 90% stenosed target lesion was located in the 3.00 mm moderately tortuous and severely calcified right coronary artery.A 330cm rotawire was selected for use.During the procedure, it was noted that the device tightened up and kinked.Also, the burr was stuck on wire and could not be withdrawn.The procedure was completed with another of the same device and the patient was stable post-procedure.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Additional Manufacturer Narrative
Device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection of the device did not identify any damages or defects.The rotawire used in the procedure was returned and used for analysis.The returned wire was able to be removed with resistance, but was not able to be reinserted due to a kink in the rotawire.In order to determine the functionality of the returned burr catheter, a test rotawire was used during analysis.During analysis, the test rotawire was able to be fully inserted and removed with no resistance or issues.E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the burr was stuck on wire.The 15 mm long and 90% stenosed target lesion was located in the 3.00 mm moderately tortuous and severely calcified right coronary artery.A 330cm rotawire and 1.50 mm rotalink burr was selected for use.During the procedure, it was noted that the device tightened up and kinked.Also, the burr was stuck on wire and could not be withdrawn.The procedure was completed with another of the same device and the patient was stable post-procedure.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 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: 21548097
• Report Number: 2124215-2025-11963
• Device Sequence Number: 4420113
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: 08714729185857
• 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): 10/14/2025

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: 02/07/2026
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0033382156
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 85 KG