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

Model Number	62080814F
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product evaluation was completed on the returned 62080814f catheter.The reported event of balloon inflation issue was confirmed.Balloon did not inflate due to leakage from the distal area of the balloon.Closer examination found that the balloon was deteriorated and many tears were observed at the distal area of the balloon.The edges of tear appeared to be matched up.No other visible damage was observed from both windings and catheter body.The engineering evaluation is anticipated.A supplemental report will be forthcoming when the investigation is completed.The lot number was not provided thus a device history record cannot be reviewed.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 a part of the monthly review.Additional fda premarket submission is k152762.
Event or Problem Description
As reported, during use in patient, the balloon of this fogarty catheter did not inflate.There was no allegation of patient injury.
Additional Manufacturer Narrative
An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As part of the manufacturing process, 100% of the units undergo a balloon inspection.Latex deterioration is "a condition usually caused by age, excessive exposure to light, atmosphere, or ozone.Appears on the balloon surface as a maze of fine cracks or crazing.The condition may occur in a small area or cover the entire balloon".Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.Complaints incidence will continue to be monitored, and applicable actions will be taken as required.

• Brand Name: FOGARTY
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21683232
• Report Number: 2015691-2025-02210
• Device Sequence Number: 20775609
• Product Code: MJN
• UDI-Device Identifier: 00690103043747
• UDI-Public: 00690103043747
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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 Model Number: 62080814F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2025
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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