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

Model Number	8575
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that device detachment occurred.Two 6f runway guide catheters were unpacked; however, devices were noted to be damaged with breakages.The procedure was completed with another of the same device.No patient complications were reported, and patient's status was stable.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).The device was returned for analysis.Visual inspection revealed kinks in the shaft 53cm and 61cm proximal of the tip, and a kink just distal of the strain relief.Product analysis confirmed the reported event as there were kinks in the shaft.
Event or Problem Description
It was reported that device detachment occurred.Two 6f runway guide catheters were unpacked; however, devices were noted to be damaged with breakages.The procedure was completed with another of the same device.No patient complications were reported, and patient's status was stable.
Additional Manufacturer Narrative
E1 - (b)(6).H10 - correction to investigation summary.Device evaluated by manufacturer: returned product consisted of a model-6f runway guide catheter.The device was visually and microscopically examined.Inspection of the hub, strain relief, shaft and tip revealed kinks in the shaft 53cm and 61cm proximal of the tip, and a kink just distal of the strain relief.Inspection of the remainder of the device found no other damage or defect.Product analysis could not confirm the reported event as there were no breaks in the shaft.
Event or Problem Description
It was reported that device detachment occurred.Two 6f runway guide catheters were unpacked; however, devices were noted to be damaged with breakages.The procedure was completed with another of the same device.No patient complications were reported, and patient's status was stable.

• Brand Name: RUNWAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17119335
• Report Number: 2124215-2023-30056
• Device Sequence Number: 6649616
• Product Code: DQY
• UDI-Device Identifier: 08714729477679
• UDI-Public: 08714729477679
• 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,Followup
• Report Date (Section B): 10/02/2023

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: 12/14/2025
• Device Model Number: 8575
• Device Catalogue Number: 8575
• Device Lot Number: 0060423002
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 09/07/2023; 09/29/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 09/26/2023; 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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