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

Model Number	3320
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the burr was leaking liquid.The 92% stenosed target lesion was located in the narrow anterior descending branch.A 1.25mm rotalink burr was selected for use.During the procedure, it was noted that the burr was leaking liquid.The procedure was completed using another of the same device.No patient complications were reported, and patient was stable after the procedure.
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).Device evaluated by manufacturer.Inspection of the device did not identify any damages or defects.After destructive testing was performed, inspection revealed that the handshake connection within the sheath, was not retrievable and further leak testing could not be completed as the sheath is blocked.Inspection of the device did not identify any damages or defects.The burr housing was dismantled as the handshake connection was not retrievable from the burr housing.The interior components were inspected for damages or defects.
Event or Problem Description
It was reported that the burr was leaking liquid.The 92% stenosed target lesion was located in the narrow anterior descending branch.A 1.25mm rotalink burr was selected for use.During the procedure, it was noted that the burr was leaking liquid.The procedure was completed using another of the same device.No patient complications were reported, and patient was stable after 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 CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20745310
• Report Number: 2124215-2024-72982
• Device Sequence Number: 12923943
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: 08714729185864
• 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): 01/09/2025

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: 11/13/2025
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0032851941
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 50 KG