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

Model Number	8575
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter had an extra ring of plastic at the tip.A 6f runway vl3.5 catheter was selected for treatment, however, an extra ring of plastic at the tip was noted upon opening the device packaging.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Date of event: used (b)(6) 2022 (first day of the bsc aware date month) as the event date was not provided.
Additional Manufacturer Narrative
B3 date of event: used 01-apr-2022 (first day of the bsc aware date month) as the event date was not provided.The device was returned for analysis.The device was visually and microscopically examined.Inspection of the hub, strain relief, shaft and tip revealed kinks in the shaft 1.5cm and 7.5cm proximal of the tip.The tip was folded backward, and the braid was protruding through the pebax.The tip was unfolded during analysis and there was a tear at the crease where the tip was folded.Inspection of the remainder of the device found no other damage or defect.The tip being folded back gave the appearance of an extra ring of plastic but no foreign matter was found.
Event or Problem Description
It was reported that the catheter had an extra ring of plastic at the tip.A 6f runway vl3.5 catheter was selected for treatment, however, an extra ring of plastic at the tip was noted upon opening the device packaging.The procedure was completed with another of the same device.No patient complications were reported.

• 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14256015
• Report Number: 2134265-2022-04991
• Device Sequence Number: 20139527
• Product Code: DQY
• UDI-Device Identifier: 08714729478973
• UDI-Public: 08714729478973
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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: 07/13/2024
• Device Model Number: 8575
• Device Catalogue Number: 8575
• Device Lot Number: 0060308083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• 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