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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC FOGARTY; CATHETER, EMBOLECTOMY
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EDWARDS LIFESCIENCES LLC FOGARTY; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 120804FP
Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2022
Event Type  malfunction  
Event Description
The patient had a clotted graft and was planned for a surgical embolectomy.They were using the size 4 arterial embolectomy catheter.The catheter was added to the surgical field and during the pre-procedure test of the device, it malfunctioned when the balloon was tested; the balloon did not expand or burst, but it did not blow up and fluid leaked out from tiny holes.A 2nd catheter from the same lot was tested and it also malfunctioned.Then, a 3rd catheter from the same lot was also tested, and also had the same malfunction.A 4th catheter from a different lot was tested and worked as expected.
 
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Brand Name
FOGARTY
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
EDWARDS LIFESCIENCES LLC
one edwards way
irvine CA 92614
MDR Report Key15426583
MDR Text Key299944112
Report Number15426583
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number120804FP
Device Catalogue Number120804FP
Device Lot Number64025084
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/09/2022
Event Location Hospital
Date Report to Manufacturer09/15/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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