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

Model Number	120804FP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	10/24/2023
Type of Reportable Event	Death
Additional 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 or Problem 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.
Additional 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.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• Common Device Name: 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 Key: 18946501
• Report Number: 2015691-2024-02157
• Device Sequence Number: 15445269
• Product Code: DXE
• UDI-Device Identifier: 00690103205213
• UDI-Public: (01)00690103205213(17)240721(11)220422(10)64320982
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/21/2024
• Device Model Number: 120804FP
• Device Lot Number: 64320982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 89 KG