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

Model Number	12TLW404F
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received in our product evaluation laboratory for a full examination.As received, part of the catheter tip, balloon latex, distal bushing, and distal winding were completely detached from catheter body and not returned.Part of the balloon latex remained attached at the proximal windings.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".No other visible damage was observed from catheter.An engineering investigation will be performed in order to consider any potential factors that may have contributed to this complaint.A supplemental report will be submitted accordingly upon investigation completion.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 surgery, the balloon of this fogarty embolectomy catheter burst.There was no allegation of patient injury.The device was available for evaluation.As per product evaluation findings, part of the catheter tip, balloon latex, distal bushing, and distal winding were completely detached from the catheter body.As confirmed, no additional intervention was needed in order to retrieve the pieces detached and the patient did not suffer any hurt.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation).Updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).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 is associated to a manufacturing or design defect.As part of the manufacturing process the units go through balloon and winding inspection process and in the final inspection 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 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: 23026557
• Report Number: 2015691-2025-07473
• Device Sequence Number: 13216382
• Product Code: DXE
• UDI-Device Identifier: 00690103043464
• UDI-Public: (01)00690103043464(17)260412(11)240112(10)65472710
• 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): 10/06/2025

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: 04/12/2026
• Device Model Number: 12TLW404F
• Device Lot Number: 65472710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2025
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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: 9 YR
• Patient Sex: Female
• Patient Weight: 25 KG