MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FOGARTY; FOGARTY THRU LUMEN EMBOLECTOMY CATHETER

Model Number	12TLW403F
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded at the facility and cannot be returned for product evaluation.The lot number is unknown, therefore, the device history record review cannot be performed.An engineering evaluation has been initiated to assess for any manufacturing related processes which could be correlated to the issue.Additional product code kra.Additional 510k number k892410.
Event or Problem Description
It was reported that during use with a fogarty thru lumen embolectomy vascular catheter, while the user was pulling the thrombus with the inflated balloon, the balloon burst.The tip of the catheter became broken.An additional incision was required to remove the fragments.All the fragments could not be completely removed.There was no patient injury or complications observed.
Additional Manufacturer Narrative
There is no product evaluation results as the device was discarded and not returned.Without its return, 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.It is not known if any procedural factors may have contributed to the reported issue.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 percent of the units go through a balloon inspection process.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.

• Brand Name: FOGARTY
• Common Device Name: FOGARTY THRU LUMEN EMBOLECTOMY CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk km 1.4; anasco PR 00610
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 21597725
• Report Number: 2015691-2025-01889
• Device Sequence Number: 12981243
• Product Code: DXE
• UDI-Device Identifier: 00690103043457
• UDI-Public: (01)00690103043457
• Combination Product (Y/N): N
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 12TLW403F
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown