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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 01/19/2024
Event Type  malfunction  
Event Description
It was reported that foreign material was present in the device.An expo diagnostic catheter was selected for use.During the procedure, the catheter was advanced in patient.However, an attempt to load the wire, the wire was not successful due to a white plastic piece being lodged in the catheter.The procedure was completed using an alternate device.No patient complications were reported.
 
Event Description
It was reported that foreign material was present in the device.An expo diagnostic catheter was selected for use.During the procedure, the catheter was advanced in patient.However, an attempt to load the wire, the wire was not successful due to a white plastic piece being lodged in the catheter.The procedure was completed using an alternate device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual and microscopic inspection found inner liner delamination.A photo provided by the customer depicted the catheter with the tip cut and the inner liner separated next to the tip.
 
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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 Key18667814
MDR Text Key334900596
Report Number2124215-2024-07052
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
Date FDA Received02/08/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7840
Device Catalogue Number7840
Device Lot Number0060497776
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2023
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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