MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR FOGARTY; THROMBECTOMY BALLOON CATHETER

Model Number	12TLW405F35
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported during use the fogarty embolectomy catheter balloon burst in an embolization case.There was no patient injury.The device is available for evaluation.
Additional Manufacturer Narrative
Additional product code includes.Kra catheter, continuous flush.A report is being submitted for this fogarty embolectomy catheter due to product evaluation findings.Report of balloon popped was confirmed.As received, the balloon was found ruptured.Balloon latex was released from proximal winding to check balloon edges at the rupture.Balloon edges did not appear to match up.Through lumen was patent without any leakage or occlusion.No other visible damage was observed from catheter body or windings.A device history record review was completed and documented that device met all specifications upon distribution.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.Therefore a root cause could not be established.As part of the manufacturing process controls 100 percent of the units go through a balloon winding and visual inspection.In this inspection the units are 100 percent visually inspected in which the integrity of the balloon is validated.In this inspection a balloon inflation test is performed.A final inspection is performed in which the integrity of the catheter, balloon, windings are validated.In the preparation section of the instructions for use ifu it is stated that inflation is usually associated with a feeling of resistance.If no resistance to inflation is encountered it should be assumed that the balloon has ruptured.Discontinue inflation at once.The catheter may continue to be used.The ifu provides instructions to check balloon integrity by inflating it to the recommended volume.Deflate balloon before insertion.Lastly the warnings section of the ifu states that pulmonary complications may result from improper inflation technique.To avoid damage to the pulmonary artery and possible balloon rupture do not inflate above the recommended volume.

• Brand Name: FOGARTY
• Common Device Name: THROMBECTOMY BALLOON CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22828419
• Report Number: 2015691-2025-06748
• Device Sequence Number: 13153463
• Product Code: DXE
• UDI-Device Identifier: 00690103043488
• UDI-Public: (01)00690103043488(17)270219(11)241120(10)66079589
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2025

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: 12TLW405F35
• Device Lot Number: 66079589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• 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: 07/24/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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