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

Model Number	12TLW805F35
Medical Device Problem Codes	Degraded (1153); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One fogarty embolectomy catheter was received by our product evaluation laboratory for a full evaluation.The report of balloon did not inflate was confirmed.As received, the balloon latex appeared deteriorated.Multiple cracks were evident on balloon latex.Leakage was observed through the cracks on the balloon.Cracks appear not matching.Through lumen was patent without any leakage or occlusion.Finally, no other visible damage was observed from catheter body.The manufacturing records were reviewed and there is no indication of a related nonconformance, all process parameters were met and inspections passed successfully.An engineering investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complain.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 of this fogarty catheter, the balloon did not inflate.There was no allegation of patient injury.The device was received for evaluation.As per product evaluation results, multiple cracks were evident on the balloon latex and cracks did not appear to match at the ruptured location.Patient demographics unable to be obtained.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation).Updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.There are controls established in the manufacturing processes to detect the condition evaluated such as the balloon visual and inflation inspection and the final inspection.Furthermore, the ifu contains instructions regarding the packaging and its storage conditions.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 23344241
• Report Number: 2015691-2025-08681
• Device Sequence Number: 9470729
• Product Code: DXE
• UDI-Device Identifier: 00690103043532
• UDI-Public: (01)00690103043532(17)260830(11)240531(10)65778285
• Combination Product (Y/N): N
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2025

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: 08/30/2026
• Device Model Number: 12TLW805F35
• Device Lot Number: 65778285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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