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

Model Number	8575
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the catheter was broken.A 6f runway catheter-guide was selected for use.During preparation, when removing the catheter from the packaging, it was noted that the tip was broken.No patient complications reported.
Event or Problem Description
It was reported that the tip of the catheter was broken.A 6f runway catheter-guide was selected for use.During preparation, when removing the catheter from the packaging, it was noted that the tip was broken.No patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The device was received in an opened product pouch, laying on the product card (out of the tabs, indicating the device was removed from the packaging).The product tray was inside the opened pouch was upside down, as the tabs for the hub were at the bottom of the packaging.This indicates the product tray was removed from the packaging and isn't how the packaging was received.The packaging was damaged (creased in pouch and tray) and there was tape at the top by the opened seal.The shaft was kinked in three (3) locations; 1.5cm proximal of the tip and 55cm and 56.5cm distal of the strain relief of the hub.The appearance of the packaging damage and kinks is consistent to damage that can occur during handling of the device during unpacking or preparation of the device at the facility.

• Brand Name: RUNWAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): AVAIL MEDICAL PRODUCTS INCORPO
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19716344
• Report Number: 2124215-2024-42107
• Device Sequence Number: 15490661
• Product Code: DQY
• UDI-Device Identifier: 08714729478973
• UDI-Public: 08714729478973
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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 Model Number: 8575
• Device Catalogue Number: 8575
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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