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

Model Number	12TLW804F
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during testing, this fogarty embolectomy catheter leaked saline.There was no allegation of patient injury.The device was available for evaluation.During the evaluation, 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
The fogarty embolectomy catheter was received for evaluation.The balloon was found to be ruptured in the middle area.The edges of latex did not match at the ruptured region.Per the 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".Through lumen was patent without any leakage or occlusion.No other visible damage or abnormality was observed from catheter body or windings.An engineering investigation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.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: h2 (type of follow-up).Updated: g3 (date received by manufacturer), h6 (type of investigation, investigation.Findings, investigation conclusions).The fogarty embolectomy catheter was received for evaluation.The balloon was found to be ruptured in the middle area.The edges of latex did not match at the ruptured region.Per the 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".Through lumen was patent without any leakage or occlusion.No other visible damage or abnormality was observed from catheter body or windings.Further investigation was performed by the engineers team.It was not able determine that the failure is related to a manufacturing / design defect.As part of the manufacturing process, all of the units go through a balloon inspection process, in which the integrity of the catheter and balloon are validated.In this inspection, the units are visually inspected; it should not have bends, wrinkles, cuts, contamination, stains, deterioration, discoloration, or ripples.Also, a final inspection is performed as per internal procedures in which the whole catheter is verified as well.It is specified that the deterioration is a condition usually caused by age, excessive exposure to light, atmosphere, or ozone that appears on the balloon surface as a maze of fine cracks or crazing.A definite root cause was unable to be determined.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.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.

• 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: 22553841
• Report Number: 2015691-2025-05886
• Device Sequence Number: 9566583
• Product Code: DXE
• UDI-Device Identifier: 00690103043518
• UDI-Public: (01)00690103043518(17)260814(11)240515(10)65694522
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: 08/14/2026
• Device Model Number: 12TLW804F
• Device Lot Number: 65694522
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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