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

Model Number	12TLW803F
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during flushing before use of this fogarty thru-lumen embolectomy catheter, balloon was damaged and leaking.In addition, there was leakage through the catheter body backform.Event was solved replacing with new unit.There was no allegation of patient injury.The device was received for evaluation.As per evaluation results, the balloon was found to be ruptured in the middle area.The edges of latex did not match at the ruptured region.
Additional Manufacturer Narrative
One fogarty embolectomy catheter was received by our product evaluation laboratory for a full examination.The report of "balloon damage" was confirmed.The report of "leakage through the catheter body backform" was unable to be confirmed.The balloon was found to be ruptured in the middle area.The edges of latex did not match at the ruptured region.Through lumen was patent without any leakage or occlusion.No other visible damage or abnormality was observed from catheter body or windings.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.
Additional Manufacturer Narrative
Added information to section b3 (date of event), h6 (type of investigation) updated section h6 (investigation findings) and h6 (investigations conclusions).Updated device evaluation: the report of balloon damage and "leakage through the catheter body backform" was confirmed.The balloon was found to be ruptured in the middle area.The edges of latex did not match at the ruptured region.A closer examination found a leakage in the inflation lumen due to a partial bond separation/gap in the adhesive at the distal end of "y" fitting.Through lumen was patent without any leakage or occlusion.No other visible damage or abnormality was observed from catheter body or windings.Lab findings were aligned with customer video.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 of balloon rupture is associated to a manufacturing or design defect.As part of the manufacturing process the units go through balloon and winding inspection process.Additionally, the ifu was reviewed and it indicates "balloon rupture and catheter separation as a result of excessive pull force applied to remove adherent material are the most frequent causes of reported failures." and "to minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation and pull force for each size catheter.".With regards to the other issue of leakage at the y-fitting, a root cause related to the manufacturing was identified.

• 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: 22182373
• Report Number: 2015691-2025-04750
• Device Sequence Number: 12934182
• Product Code: DXE
• UDI-Device Identifier: 00690103043501
• UDI-Public: (01)00690103043501(17)250822(11)230524(10)65105742
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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: 08/22/2025
• Device Model Number: 12TLW803F
• Device Lot Number: 65105742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2025
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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