MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUNWAY; CATHETER, PERCUTANEOUS

Model Number	8575
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter fracture occurred.The patient presented for left coronary catheterization.A runway guide catheter was selected for use but during the procedure, there was a catheter fracture.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that catheter fracture occurred.The patient presented for left coronary catheterization.A runway guide catheter was selected for use but during the procedure, there was a catheter fracture.The procedure was completed with another of same device.No patient complications were reported.It was further reported that the shaft was kinked and not fractured.
Additional Manufacturer Narrative
Returned device consisted of a model-6f runway fl4 was returned for analysis.Visual and microscopic observation at the catheter hub, shaft, and distal tip identified a single kink at the catheter hub.No further damage was observed from the device.

• Brand Name: RUNWAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14408175
• Report Number: 2134265-2022-05572
• Device Sequence Number: 2479570
• Product Code: DQY
• UDI-Device Identifier: 08714729477686
• UDI-Public: 08714729477686
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K033441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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: 05/10/2024
• Device Model Number: 8575
• Device Catalogue Number: 8575
• Device Lot Number: 0060295705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2021
• 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: Unknown