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
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product 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.
Event or Problem Description
As reported, during use in patient, this fogarty embolectomy catheter was detached from the backform.The broken part did not remained inside the patient.Therefore, no additional intervention was needed.There was no allegation of patient injury.
Additional Manufacturer Narrative
Added information to section d9 and h6 (type of investigation) updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).The device was received for evaluation.The report of "catheter was detached from the backform" was 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.The findings were aligned to the customer photo.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 it cannot be confirmed that this complaint is associated to a manufacturing/design defect.As part of the manufacturing process, the units go through a final visual inspection for catheter tube integrity and leaks.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 22184163
• Report Number: 2015691-2025-04755
• Device Sequence Number: 8570543
• 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): 08/04/2025

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
• Device Expiration Date: 08/14/2026
• Device Model Number: 12TLW804F
• Device Lot Number: 65694522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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: 40 YR
• Patient Sex: Male