MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER; CATHETER, EMBOLECTOMY

Model Number	12TLW805F35
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fogarty embolectomy catheter was received for a full evaluation.The report of "failed the inflation" was confirmed.As received, the catheter body was broken next to y-adapter.The cross surface of broken section appeared uneven and rough.The catheter body matched at the broken location.Finally, no other visible damage was observed from catheter body, balloon, or windings.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.Based on the available information, there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.The manufacturing process have the controls to detect this conditions, where the units are inspected according to plan specifications, the balloon is visually inspected, and for inflation and deflation, the catheter is inspected for obstruction or restricted tube, for hub / shrink leakage and for bushings and tip leakage.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.
Event or Problem Description
As reported, during use in patient, the balloon of this fogarty embolectomy catheter failed the inflation.No further information was available.There was no allegation of patient injury.The device was received for evaluation and the catheter body was broken into two pieces.Patient demographics unable to be obtained.

• Brand Name: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER
• Common Device Name: 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 ; 9492017706
• MDR Report Key: 23494701
• Report Number: 2015691-2025-09122
• Device Sequence Number: 13023682
• Product Code: DXE
• UDI-Device Identifier: 00690103043532
• UDI-Public: (01)00690103043532(17)270127(11)241028(10)66035835
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K240078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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 Model Number: 12TLW805F35
• Device Lot Number: 66035835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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 Sex: Unknown