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

Model Number	12TLW404F
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon of this fogarty catheter ruptured when it was inflated and pulled to remove the blood clot at the anastomotic site during use.Patient demographics were requested but unavailable.There were no patient complications reported.
Additional Manufacturer Narrative
A medical device report is being submitted for this returned 12tlw404f vascular catheter due to product evaluation findings.Customer report of the balloon of this fogarty catheter ruptured was confirmed.The balloon was found to be ruptured.The ruptured edges did not appear to match up.No visible damage or inconsistency was observed from catheter body and windings.Through lumen was patent without any leakage or occlusion.The lot history review was performed for lot number 65808263 in 630463049 and no other complaint with the same lot number or defect code was evaluated related to this nonconformance for thru-lumen product models.Per the ifu "balloon rupture and catheter separation as a result of excessive pull force applied to remove adherent material are the most frequent causes of reported failures." and "to minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation volume and pull force for each size catheter.".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 design defect.Therefore, a root cause could not be established.As part of the manufacturing process, 100% of the manufactured units go through a balloon inflation process performed as per procedure.

• Brand Name: FOGARTY
• Common Device Name: FOGARTY THRU-LUMEN EMBOLECTOMY 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: erika bonilla ; one edwards way; irvine, CA 92614
• MDR Report Key: 21356571
• Report Number: 2015691-2025-00932
• Device Sequence Number: 7854077
• Product Code: DXE
• UDI-Device Identifier: 00690103043464
• UDI-Public: (01)00690103043464(17)260930(11)240701(10)65808263
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2025

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: 09/30/2026
• Device Model Number: 12TLW404F
• Device Lot Number: 65808263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2025
• 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: 01/23/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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