MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FOGARTY; FOGARTY THRU LUMEN EMBOLECTOMY CATHETER 3F 120CM

Model Number	12TLW1203F
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded at the facility and is not available for return and product evaluation.The instructions for use (ifu) warns "the possibility of balloon rupture must be taken into account when considering the risks involved in any embolectomy procedure.To minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation volume and pull force for each size catheter." the ifu also instructs the customer to inspect the catheter with the balloon inflated during purging.The device history record review is pending.Once the results are available, they will be submitted in a supplemental report.Additional product code, kra.Additional 510k number, k892410.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.The facility submitted a voluntary medwatch, mw5164423.
Event or Problem Description
As reported, there was a failure with a fogarty embolectomy catheter.During use, the surgeon inserted the fogarty catheter through the bronchoscope into the patient's chest cavity.When the balloon was attempted to be inflated, the surgeon realized the balloon had popped.Biopsy forceps were used to retrieve the balloon, however, there were no balloon remnants found.There is no patient injury.
Additional Manufacturer Narrative
There is no product evaluation as the device was discarded and not returned.Without its return, it is not possible to determine if there was damage or a defect that existed on the unit that could have contributed to the event.It is not known if any procedural factors may have contributed to the reported issue.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As the complaint could not be confirmed, there is not sufficient evidence to determine a root cause.As part of the manufacturing process 100 percent of the units go through a balloon inspection process.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.The device history record review was completed and all manufacturing inspections passed with no non conformances.

• Brand Name: FOGARTY
• Common Device Name: FOGARTY THRU LUMEN EMBOLECTOMY CATHETER 3F 120CM
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• 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: 21355569
• Report Number: 2015691-2025-00923
• Device Sequence Number: 12683920
• Product Code: DXE
• UDI-Device Identifier: 00690103177657
• UDI-Public: (01)00690103177657(17)260530(11)240229(10)65650510
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K240078
• 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): 03/13/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2026
• Device Model Number: 12TLW1203F
• Device Lot Number: 65650510
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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
• Patient Age: 55 YR
• Patient Sex: Male