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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES PR FOGARTY ARTERIAL EMBOLECTOMY CATHETER; FOGARTY CATHETER Back to Search Results
Model Number 120804FP
Device Problem Break (1069)
Patient Problem Foreign Body Embolism (4439)
Event Date 10/24/2023
Event Type  Death  
Manufacturer Narrative
The device was discarded and not available to be returned.The device history record review is pending.A supplemental report will be submitted when the investigation has been completed.An engineering task has been assigned for further investigation.H3 other text: discarded.
 
Event Description
It was reported in medwatch (b)(4).That there was a failure with the fogarty embolectomy catheter.A 3 french fogarty catheter was placed retrograde in the superficial femoral artery sfa.Fresh thrombus was removed.Then a 4 french fogarty catheter was placed and a second pass was performed but it became lodged as it was being pulled back.There were many manipulations attempted, but they were unable to dislodge it.Negative pressure was placed on the catheter and then traction placed.The balloon ruptured and then the catheter came out.It appeared that some of the balloon remained in the patient.An angiogram was performed down the leg.There appeared to be a severe stenosis in the proximal third of the sfa 80 percent.It looked as though the balloon had become stuck at the location of the severe stenosis.The balloon was successfully retrieved through a fasciotomy.Through follow up with the facility it was determined that the patient status is deceased.Date of death and cause have been requested from the facility with no response.Follow up for more information is still ongoing.The 4 french fogarty catheter was discarded and not available for evaluation.
 
Manufacturer Narrative
New information received from facility states that the regarding date and cause of death.Cause of death was determined to be cardiac arrest on (b)(6) 2024.There was no subsequent procedure performed to remove the balloon piece from the stenosed section of the superficial femoral artery.It was confirmed that the procedure was an embolectomy and stent placement performed on (b)(6) 2023.Medical records have been requested, but not provided.The device history record review was completed and all inspections passed with no non-conformances.
 
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Brand Name
FOGARTY ARTERIAL EMBOLECTOMY CATHETER
Type of Device
FOGARTY CATHETER
Manufacturer (Section D)
EDWARDS LIFESCIENCES PR
state rd indus pk km 1.4
anasco, puerto rico
Manufacturer (Section G)
EDWARDS LIFESCIENCES PR
state rd indus pk km 1.4
anasco PR 00610
Manufacturer Contact
katheryn cespedes
1 edwards way
irvine, CA 92614
9492017706
MDR Report Key18946501
MDR Text Key338184533
Report Number2015691-2024-02157
Device Sequence Number1
Product Code DXE
UDI-Device Identifier00690103205213
UDI-Public(01)00690103205213(17)240721(11)220422(10)64320982
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number120804FP
Device Lot Number64320982
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/20/2024
Supplement Dates Manufacturer Received03/22/2024
Supplement Dates FDA Received04/05/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/22/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization;
Patient Age72 YR
Patient SexMale
Patient Weight89 KG
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