MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPO GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	7800
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device fracture occurred.The stenosed target lesion was located in the aortic root.A 110cm 5f expo guide catheter was selected for use.During the procedure, it was noted that the pigtail catheter broke near the tip while trying to advance across aortic valve.The device was pulled out through the sheath and the procedure was completed.There were no patient complications reported post procedure.
Event or Problem Description
It was reported that a device fracture occurred.The stenosed target lesion was located in the aortic root.A 110cm 5f expo guide catheter was selected for use.During the procedure, it was noted that the pigtail catheter broke near the tip while trying to advance across aortic valve.The device was pulled out through the sheath and the procedure was completed.There was no patient complications reported post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The device was returned for analysis.Inspection of the device found the tip was separated (shaft break) at 5cm.Inspection under the microscope found no damage or defect.Examination in the x-ray revealed the tip separated (shaft break) at the bond, where the braid ended.

• Brand Name: EXPO GUIDE CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 20835915
• Report Number: 2124215-2024-76111
• Device Sequence Number: 18302357
• Product Code: DQO
• UDI-Device Identifier: 08714729187905
• UDI-Public: 08714729187905
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K120495
• 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): 03/17/2025

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: 07/24/2026
• Device Model Number: 7800
• Device Catalogue Number: 7800
• Device Lot Number: 0060575722
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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