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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPO GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION EXPO GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 7840
Device Problems Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2023
Event Type  malfunction  
Event 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 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.
 
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 passed through the entire length.Inspection under the microscope revealed inner liner delamination from the tip to 6cm proximal of the tip.There was no liner present at the tip.Fourier-transform infrared spectroscopy (ftir) was performed to identify a piece returned separately and confirmed it to be consistent with the inner liner material.The returned sections of the liner measured 1cm and 1.5cm.A review of the photo provided by the site showed a piece of the inner liner separated from the catheter, confirming the reported event.
 
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Brand Name
EXPO GUIDE CATHETER
Type of Device
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 Key18268269
MDR Text Key329741466
Report Number2124215-2023-68843
Device Sequence Number1
Product Code DQO
UDI-Device Identifier08714729187813
UDI-Public08714729187813
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120495
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/17/2024
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
Device Operator Health Professional
Device Model Number7840
Device Catalogue Number7840
Device Lot Number0060490176
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/16/2023
Initial Date FDA Received12/05/2023
Supplement Dates Manufacturer Received03/28/2024
Supplement Dates FDA Received04/17/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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