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

Model Number	8575
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.
Event or Problem Description
It was reported that fractured catheter occured.A runway guiding catheter was selected for treatment.However, a fractured catheter was observed.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that fractured catheter occured.A runway guiding catheter was selected for treatment.However, a fractured catheter was observed.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
B3 date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.Device evaluated by mfr.: inspection of the hub, strain relief, shaft and tip revealed the shaft was flattened 38-40.5cm distal of the strain relief.There was a kink 44.5cm distal of the strain relief.Inspection of the remainder of the device found no other damage or defect.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12823590
• Report Number: 2134265-2021-14381
• Device Sequence Number: 5647503
• Product Code: DQY
• UDI-Device Identifier: 08714729478386
• UDI-Public: 08714729478386
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

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: Other
• Device Expiration Date: 06/15/2024
• Device Model Number: 8575
• Device Catalogue Number: 8575
• Device Lot Number: 0060302666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown