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

Model Number	12TLW803F
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during preoperative testing of this fogarty embolectomy catheter, the balloon was found to be ruptured.There was no allegation of patient injury.The device was received for evaluation and the balloon was found completely broken in the middle area; the latex edges at the rupture site did not match.
Additional Manufacturer Narrative
The device was received for evaluation.Report of "balloon ruptured" was confirmed.During visual inspection, the balloon was found completely broken in the middle area.The edges of latex did not match at the ruptured region.Rupture part was not returned.Through lumen was patent without any leakage or occlusion.No other visible damage or abnormality was observed from catheter body 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 being evaluated to be associated to a manufacturing/design defect.As part of the manufacturing process the units go through balloon and winding inspection.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".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 ; 9492017706
• MDR Report Key: 24908018
• Report Number: 2015691-2026-14440
• Device Sequence Number: 21314321
• Product Code: DXE
• UDI-Device Identifier: 00690103043501
• UDI-Public: (01)00690103043501(17)270530(11)250228(10)66259608
• 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): 04/17/2026

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: 12TLW803F
• Device Lot Number: 66259608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 51 KG