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

Model Number	12TLW804F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One swan-ganz catheter was received by our product evaluation laboratory for a full examination.The reported issue was not be confirmed.As received, catheter body tube was completely broken off from the distal end of the "y" fitting.The cross surfaces of broken tube were rough and uneven.The edges of the broken section appeared to match at the break site.Both balloon latex and balloon windings were intact.Lab findings were not aligned to the customer photo, which shows the catheter body not broken.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.Further engineering investigation was performed, when the product investigation is completed, a supplemental report will be sent with the investigation results.
Event or Problem Description
As reported, during surgery, the balloon of this embolectomy catheter ruptured (see picture attached).There is no allegation of patient injury.As per product evaluation findings, catheter body tube was completely broken off from the distal end of the "y" fitting.The cross surfaces of broken tube were rough and uneven.The edges of the broken section appeared to match at the break site.Patient demographics were not provided.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation) updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).Based on the available information, there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.The manufacturing process have the controls to detect this conditions where all the units are inspected according to plan specifications, such as balloon is visual inspection and catheter inspection for obstruction or restricted tube and leakage.

• 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, puerto rico
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 24015182
• Report Number: 2015691-2026-10279
• Device Sequence Number: 9136751
• Product Code: DXE
• UDI-Device Identifier: 00690103043518
• UDI-Public: (01)00690103043518(17)260530(11)240229(10)65631854
• 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): 02/16/2026

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 Expiration Date: 05/30/2026
• Device Model Number: 12TLW804F
• Device Lot Number: 65631854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2025
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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