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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY ARTERIAL EMBOLECTOMY CATHETER; CATHETER, EMBOLECTOMY

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EDWARDS LIFESCIENCES, PR FOGARTY ARTERIAL EMBOLECTOMY CATHETER; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 140808
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/11/2023
Event Type  malfunction  
Event Description
As reported, during use in patient of this fogarty corkscrew catheter, the distal tip was bent and the handle did not work.There was no allegation of patient injury.Patient demographics unable to be obtained.The device was available for evaluation.
 
Manufacturer Narrative
The fogarty corkscrew catheter was received by our by our product evaluation laboratory for a full examination.The report of distal tip bent was confirmed.However, report of "handle did not work" was unable to be confirmed.The distal tip was received kinked/bent and the spiral cable was exposed through a tear of approximately 1mm in length in the latex membrane.The edges of the torn region appeared to match up.There was no visible damage observed to the catheter body.It was able to move the thumb slide on the handle forwards and backwards and the membrane extended and contracted respectively.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.A visual and functional inspection is performed to the catheters as part of the manufacturing process.The ifu was reviewed and it indicates: " exposure to the atmosphere, handling during insertion, and plaque and other deposits within the blood vessel may cause latex membrane degradation." and " to minimize the risk of vessel or membrane damage, do not exceed the maximum recommended pull force".Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
 
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Brand Name
FOGARTY ARTERIAL EMBOLECTOMY CATHETER
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
EDWARDS LIFESCIENCES, PR
state rd indus pk 402 km 1.4
anasco PR 00610
Manufacturer (Section G)
EDWARDS LIFESCIENCES, PR
state rd indus pk 402 km 1.4
anasco PR 00610
Manufacturer Contact
samantha eveleigh
1 edwards way
irvine, CA 92614
9492503939
MDR Report Key18787815
MDR Text Key336341038
Report Number2015691-2024-01377
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K193379
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/27/2024
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 Number140808
Device Lot Number64997508
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/07/2024
Initial Date FDA Received02/27/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2023
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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