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

Model Number	H74908526211
Medical Device Problem Codes	Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign matter was present in the device.Two 5f expo guide catheters were selected for use.During the procedure, before the catheter entered the patient, it was noted that the guidewire would not load thru the diagnostic catheter.The guidewire was getting stuck in the middle of the body of the catheter.A second catheter was opened, and the same issue occurred.The catheters were then cut open and a white plastic foreign material was found to be occluding the lumen of the catheters.The procedure was completed with a similar device.No patient complications were reported.
Additional Manufacturer Narrative
This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.
Event or Problem Description
It was reported that foreign matter was present in the device.Two 5f expo guide catheters were selected for use.During the procedure, before the catheter entered the patient, it was noted that the guidewire would not load thru the diagnostic catheter.The guidewire was getting stuck in the middle of the body of the catheter.A second catheter was opened, and the same issue occurred.The catheters were then cut open and a white plastic foreign material was found to be occluding the lumen of the catheters.The procedure was completed with a similar device.No patient complications were reported.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18406515
• Report Number: 2124215-2023-72977
• Device Sequence Number: 16812683
• Product Code: DQO
• UDI-Device Identifier: 08714729187813
• UDI-Public: (01)08714729187813(17)250817(10)60488290
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/03/2024

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 Expiration Date: 08/17/2025
• Device Model Number: H74908526211
• Device Catalogue Number: 7840
• Device Lot Number: 0060488290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• 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