MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY ARTERIAL EMBOLECTOMY CATHETER WITH GATE VALVE; CATHETER, EMBOLECTOMY

Model Number	120803F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Follow up is on going to clarify whether the device is available for evaluation.An investigation has been initiated to consider any potential factors that may have contributed to this complaint.A supplemental report will be forthcoming with the evaluation 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, when trawling during a popliteal artery embolectomy of this fogarty embolectomy catheter, the balloon dislodged in the vessel.The balloon could not be retrieved using a new fogarty embolectomy catheter.
Additional Manufacturer Narrative
Added information to section a2, a3, a4, h6 (type of investigation).Updated section h6(component code),h6 (investigation findings) and h6 (investigations conclusions).No product was received for evaluation.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.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.As part of the manufacturing process, the manufactured units go through a balloon inflation process.
Additional Manufacturer Narrative
Updated section d9 and h6 (type of investigation).Finally, the device was received for evaluation.The report of balloon issue was confirmed.As received, balloon, distal winding and spring were missing.Proximal windings were found to be unraveled.No other visible damage was observed form catheter body.
Additional Manufacturer Narrative
The manufacturing process have the controls to detect conditions related to balloon or windings, in which the general appearance of the catheter and balloon are verified.Also, the windings of the balloon and the balloon are inspected.In addition, in the instructions for use ifu it is indicated that the balloon rupture and catheter separation are the most frequent causes of reported failures as a result of excessive pull force applied to remove adherent material.Also, it is specified that to minimize the risk of vessel damage, balloon rupture, or tip detachment, the maximum recommended inflation and pull force for each size catheter must not be exceed.Based on the available information there is no evidence that supports or confirms theses failure modes are associated to a manufacturing or design defect.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER WITH GATE VALVE
• 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: 21933800
• Report Number: 2015691-2025-03386
• Device Sequence Number: 15633284
• Product Code: DXE
• UDI-Device Identifier: 00690103043280
• UDI-Public: (01)00690103043280(17)250924(11)230626(10)65129588
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/06/2026

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 Expiration Date: 09/24/2025
• Device Model Number: 120803F
• Device Lot Number: 65129588
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 06/02/2025; 07/17/2025; 02/27/2026
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/03/2025; 08/04/2025; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 94 KG