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

Model Number	12TLW805F35
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda product codes include: kra- catheter, continuous flush.The device evaluation is anticipated.A supplemental report will be forthcoming when the investigation is completed.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.
Event or Problem Description
It was reported that during use of the fogarty catheter it would either not inflate or was difficult to inflate and then not deflate.The catheter was removed from the patient once the issue was noticed.There was no patient injury.
Additional Manufacturer Narrative
The device was not returned for product evaluation.Without return of the unit, it is not possible to determine if there was damage or a defect that existed on the unit that could have contributed to the event or if any procedural factors may have contributed to the reported issue.The device history record review was completed and the product passed without nonconformances.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As the complaint could not be confirmed, there is not sufficient evidence to determine a root cause.As part of the manufacturing process 100% of the units go through a balloon winding and full visual inspection.The instructions for use also contains the following warning : use of liquid inflation media will result in slower inflation/deflation rates.

• Brand Name: FOGARTY
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): BD APM; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 23785791
• Report Number: 2015691-2025-09959
• Device Sequence Number: 13379506
• Product Code: DXE
• UDI-Device Identifier: 00690103043532
• UDI-Public: (01)00690103043532(17)270828(11)250529(10)66621569
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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 Model Number: 12TLW805F35
• Device Lot Number: 66621569
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2025
• 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