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); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was stuck with the guidewire.The target lesion was located in the left anterior descending artery.A 1.25mm rotalink burr and a rotawire were selected for use.During the procedure, it was noted that the rotalink burr was stuck with the rotawire, the advancer was leaking gas, and the procedure could not be performed normally.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6), e1 - initial reporter address 1: (b)(6), e1 - initial reporter phone: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that the burr was stuck with the guidewire.The target lesion was located in the left anterior descending artery.A 1.25mm rotalink burr and a rotawire were selected for use.During the procedure, it was noted that the rotalink burr was stuck with the rotawire, the advancer was leaking gas, and the procedure could not be performed normally.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.It was further reported that the rotalink burr and rotawire were stuck together and could not be separated.The devices were difficult to remove, but they were eventually removed as a whole.
Event or Problem Description
It was reported that the burr was stuck with the guidewire.The target lesion was located in the left anterior descending artery.A 1.25mm rotalink burr and a rotawire were selected for use.During the procedure, it was noted that the rotalink burr was stuck with the rotawire, the advancer was leaking gas, and the procedure could not be performed normally.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.It was further reported that the rotalink burr and rotawire were stuck together and could not be separated.The devices were difficult to remove, but they were eventually removed as a whole.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Manuf analysis: returned product consisted of the rotalink burr catheter which was returned connected to a rotablator rotalink advancer.Product analysis confirmed the reported events as was there were numerous kinks to the wire causing significant resistance when removing during device analysis.The severity of damage present prevented reinsertion.No damage or irregularity was found to the returned complaint burr catheter device.Media provided with the complaint depicts a bent coil and an advancer with no damage.The media does not provide additional clarity to the cause of the reported event.

• 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: 22707453
• Report Number: 2124215-2025-49927
• Device Sequence Number: 15892617
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: (01)08714729185864(17)260912(10)34835083
• 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,Followup
• Report Date (Section B): 11/07/2025

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: 09/12/2026
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0034835083
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 10/10/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 08/20/2025; 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 76 KG