MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY OCCLUSION CATHETER; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	620404F
Medical Device Problem Codes	Device Slipped (1584); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, after insertion of this fogarty occlusion catheter, the balloon inflated deformed with rupture on the attachment point.The balloon was deflated and removed from the patient.There was no allegation of patient injury.Patient demographics were requested and unable to be obtained.
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, after insertion of this fogarty occlusion catheter, the balloon inflated deformed with rupture on the attachment point.The balloon was deflated and removed from the patient.There was no allegation of patient injury.The device was received for evaluation and the distal windings were found to be unraveled.
Additional Manufacturer Narrative
Updated information section b5, d9 and h6 (device code), h6 (type of investigation) the device was received for evaluation.The report of balloon issue was confirmed.The balloon was found ruptured at distal tip.Distal windings were found to be unraveled.Distal windings were removed to check balloon edges at the rupture.Ruptured edges appeared to match up.Proximal windings were intact.No other visible damage or abnormality was observed from catheter body.
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 and the evaluation, the failure mode could not be confirmed to be associated to a manufacturing defect.A root cause could not be determined.No deficiencies were found the manufacturing process.The winding tension parameter and all the specifications for the tip forming execution were documented correctly.All the units go through the inspections at the drilling procedure and winding and balloon inspections.

• Brand Name: FOGARTY OCCLUSION CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• 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, puerto rico
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 22563050
• Report Number: 2015691-2025-05932
• Device Sequence Number: 18448818
• Product Code: MJN
• UDI-Device Identifier: 00690103043723
• UDI-Public: (01)00690103043723(17)260718(11)240418(10)65694513
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211610
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2025

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: 07/18/2026
• Device Model Number: 620404F
• Device Lot Number: 65694513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 08/12/2025; 09/30/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/05/2025; 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown