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

Model Number	12TLW803F
Medical Device Problem Codes	Degraded (1153); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.Report of "balloon failed to inflate" was confirmed.As received, the balloon did not inflate due to balloon rupture at central area, approximately 2mm in length.The balloon edges did not appear to match up at the ruptured location.Both balloon windings were intact.The through lumen was patent without any leakage or occlusion.No visible damage was observed from the catheter.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 is associated to a manufacturing or design defect.As part of the manufacturing process, the units go through a balloon inspection, in which the integrity of the catheter and the balloon are validated, and a final visual inspection.Also, as per specification, latex deterioration is "a condition usually caused by age, excessive exposure to light, atmosphere, or ozone.Appears on the balloon surface as a maze of fine cracks or crazing.The condition may occur in a small area or cover the entire balloon".Furthermore, as per ifu "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".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 preoperative inspection of this fogarty embolectomy catheter, the balloon failed to inflate.Visual examination revealed signs of latex deterioration.In addition, a fluid test was performed and few tiny drops were observed leaking.There was no allegation of patient injury.The device was available for evaluation.The device was received for evaluation and the balloon was ruptured at the central area; the balloon edges did not appear to match up at the ruptured location.

• 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 ; 9492503939
• MDR Report Key: 23355454
• Report Number: 2015691-2025-08709
• Device Sequence Number: 21048052
• Product Code: DXE
• UDI-Device Identifier: 00690103043501
• UDI-Public: (01)00690103043501(17)260415(11)240115(10)65391816
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/22/2025

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: 04/15/2026
• Device Model Number: 12TLW803F
• Device Lot Number: 65391816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 64 KG