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

Model Number	H74908526221
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	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign matter was present in the device lumen.A5f expo fl3.5 diagnostic catheter was selected for use.A 0.035-inch non-boston scientific (non-bsc) wire was introduced through the catheter outside the patient, but the wire would not advance near the first and second device curves.When more effort was applied, suddenly the wire advanced out the tip of the expo catheter and a large white chunk of plastic debris exited the catheter.The same thing occurred with a 5f expo fl4 diagnostic catheter.The procedure was completed using an alternate method and there were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.During visual inspection no damage or defect was observed.An examination of the device x-ray found evidence of inner liner delamination.A 0.35-inch test guidewire was inserted in the distal tip end and met resistance.The wire was inserted in the hub end and met resistance in the same location.Inspection under the microscope revealed inner liner delamination 6cm proximal of the tip to where a section of the liner came out.Fourier-transform infrared spectroscopy (ftir) was performed to identify a piece returned separately and confirmed it to be consistent with the inner liner material.A review of the photo provided by the site showed a piece of the inner liner separated from the catheter, confirming the reported event.
Event or Problem Description
It was reported that foreign matter was present in the device lumen.A5f expo fl3.5 diagnostic catheter was selected for use.A 0.035-inch non-boston scientific (non-bsc) wire was introduced through the catheter outside the patient, but the wire would not advance near the first and second device curves.When more effort was applied, suddenly the wire advanced out the tip of the expo catheter and a large white chunk of plastic debris exited the catheter.The same thing occurred with a 5f expo fl4 diagnostic catheter.The procedure was completed using an alternate method and there were no patient complications.
Event or Problem Description
It was reported that foreign matter was present in the device lumen.A5f expo fl3.5 diagnostic catheter was selected for use.A 0.035-inch non-boston scientific (non-bsc) wire was introduced through the catheter outside the patient, but the wire would not advance near the first and second device curves.When more effort was applied, suddenly the wire advanced out the tip of the expo catheter and a large white chunk of plastic debris exited the catheter.The same thing occurred with a 5f expo fl4 diagnostic catheter.The procedure was completed using an alternate method and there were no patient complications.
Additional Manufacturer Narrative
This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.Device evaluated by mfr.: the device was returned for analysis.During visual inspection no damage or defect was observed.An examination of the device x-ray found evidence of inner liner delamination.A 0.35-inch test guidewire was inserted in the distal tip end and met resistance.The wire was inserted in the hub end and met resistance in the same location.Inspection under the microscope revealed inner liner delamination 6cm proximal of the tip to where a section of the liner came out.Fourier-transform infrared spectroscopy (ftir) was performed to identify a piece returned separately and confirmed it to be consistent with the inner liner material.A review of the photo provided by the site showed a piece of the inner liner separated from the catheter, confirming the reported event.

• 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: 18268285
• Report Number: 2124215-2023-68845
• Device Sequence Number: 19854538
• Product Code: DQO
• UDI-Device Identifier: 08714729187820
• UDI-Public: (01)08714729187820(17)250725(10)60481596
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,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: 07/25/2025
• Device Model Number: H74908526221
• Device Catalogue Number: 7840
• Device Lot Number: 0060481596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 03/28/2024; 06/11/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 04/17/2024; 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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