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	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip got fractured.A runway catheter-guide was selected for use.During the procedure, it was noted that the device tip got fractured.No patient complications were reported.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Conclusion: based on a thorough review of the reported complaint, the conclusion code for this complaint was considered 'cause not established'.The reported event indicated that during the procedure, it was noted that the tip got fractured.During manufacturing strict quality practices are in place to safeguard against any devices that do not meet boston scientific corporation (bsc) strict quality process and controls in place.With a lack of reported procedural information and the unavailability of the device for product analysis, it is unknown what the cause of the event/damage as the reported information doesn't lead to a clear conclusion of the cause.
Event or Problem Description
It was reported that the tip got fractured.A runway catheter-guide was selected for use.During the procedure, it was noted that the device tip got fractured.No patient complications were reported.

• Brand Name: RUNWAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 20833311
• Report Number: 2124215-2024-75718
• Device Sequence Number: 4159563
• Product Code: DQY
• UDI-Device Identifier: 08714729477891
• UDI-Public: 08714729477891
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 04/06/2026
• 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