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

Model Number	120403F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported during use the tip balloon of a fogarty catheter may have fallen off inside the brachial radial artery.The catheter balloon portion was noted to be disassembled upon removal.Per the physician it was left in the patients left forearm.There was no patient injury.The device will not be available for evaluation.
Additional Manufacturer Narrative
The device was not available for evaluation, therefore, a product evaluation could not be completed.Without the return of the device, 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.The device history record review was completed and documented that the device met all specifications upon distribution.As the complaint could not be confirmed, there is not sufficient evidence to determine a root cause.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 ARTERIAL 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: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22115233
• Report Number: 2015691-2025-04290
• Device Sequence Number: 19896372
• Product Code: DXE
• UDI-Device Identifier: 00690103043242
• UDI-Public: (01)00690103043242(17)270131(11)241101(10)66104672
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K810352
• 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): 05/30/2025

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: 120403F
• Device Lot Number: 66104672
• Was Device Available for Evaluation?: No
• 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: 05/06/2025
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 76 KG