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

Model Number	12TLW805F35
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The reported issue was confirmed.As received, during visual inspection balloon was found completely broken.The balloon edges did not match at the ruptured region.The rupture part was not returned.All through lumens were patent without any leakage or occlusion.Finally, no other visible damage or abnormality was observed from catheter body and windings.The manufacturing records were reviewed 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 or design defect.As part of the manufacturing process the units go through balloon and winding inspection process.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, the balloon of this fogarty embolectomy catheter burst.There is no allegation of missing pieces.No additional intervention was required.There was no allegation of patient injury.The device was received for evaluation and the balloon edges did not match at the ruptured region.Patient demographics unable to be obtained.

• Brand Name: CATHETER, EMBOLECTOMY
• Common Device Name: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 25252216
• Report Number: 2015691-2026-15451
• Device Sequence Number: 5417723
• Product Code: DXE
• UDI-Device Identifier: 00690103043532
• UDI-Public: (01)00690103043532(17)270616(11)250317(10)66259616
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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
• Device Model Number: 12TLW805F35
• Device Lot Number: 66259616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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 Sex: Unknown