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

Model Number	120803FS
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation; it was discarded at the hospital.One image corresponding to this fogarty arterial embolectomy catheter was provided for evaluation.Image showed what appeared to be a balloon of a vascular catheter.Distal tip appeared to be bent.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, upon opening of package of this fogarty arterial embolectomy catheter, balloon was found burst leaving internal wire exposed.There was no allegation of patient injury.The device was not available for evaluation since it was discarded.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation) updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).Without return of the product, it is unable to perform a complete investigation of the reported event.The customer report of balloon burst was unable to be confirmed based on the image provided.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 units go through a balloon and visual inspection where the units are visually inspected and in which the integrity of the catheter and balloon are validated.Additionally, concerning the other issue of bent distal tip, based on the available information cannot be determined that the failure is related 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: 23320743
• Report Number: 2015691-2025-08558
• Device Sequence Number: 9948485
• Product Code: DXE
• UDI-Device Identifier: 00690103043297
• UDI-Public: (01)00690103043297(17)270312(11)241211(10)66150830
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2025

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 Model Number: 120803FS
• Device Lot Number: 66150830
• Was Device Available for Evaluation?: No
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2024
• 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 Sex: Unknown