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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 7760
Device Problems Fracture (1260); Difficult to Insert (1316); Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2024
Event Type  malfunction  
Event Description
It was reported that the device was fractured.A model-5f expo multipack 145 (5pkx3) was selected for percutaneous coronary intervention (pci).During the procedure, the expo catheter multipack found to have a stricture in the 'l' catheter of multiple catheters in the pack which made them difficult to flush and impossible to pass a wire.Furthermore, it was noted that the device was fractured.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.
 
Manufacturer Narrative
H6: device codes: corrected from difficult to insert a150206 to difficult to advance a150205.
 
Event Description
It was reported that the device was fractured.A model-5f expo multipack 145 (5pkx3) was selected for percutaneous coronary intervention (pci).During the procedure, the expo catheter multipack found to have a stricture in the 'l' catheter of multiple catheters in the pack which made them difficult to flush and impossible to pass a wire.Furthermore, it was noted that the device was fractured.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.
 
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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)
AVAIL MEDICAL PRODUCTS INCORPO
6201 america center drive
san jose CA 95002
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18730450
MDR Text Key336741006
Report Number2124215-2024-08118
Device Sequence Number1
Product Code DQO
UDI-Device Identifier08714729187875
UDI-Public08714729187875
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 Physician
Type of Report Initial,Followup
Report Date 03/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7760
Device Catalogue Number7760
Device Lot Number0060498231
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/20/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/22/2023
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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