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

Model Number	120803F
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fogarty arterial embolectomy 120803f balloon tip burst in a patient during a procedure.No patient injury was reported and no demographics were available.There will be no product return.
Additional Manufacturer Narrative
The device was not returned therefore no evaluation could be performed since no objective evidence such as product samples, imagery, or videos was provided for investigation.The lot number was not provided thus a device history record was not reviewed.As such, based on available information, a definite root cause is unable to be determined at this time.The reported malfunction could not be confirmed since no product samples nor images was provided, however, there are manufacturing controls to avoid potential causes related to the malfunction such as 100% visual inspction, manufacturing continuous monitor sampling, and qa sampling inspection.Complaint histories for all reported events are reviewed against trending control limits, 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: erika bonilla ; one edwards way; irvine, CA 92614
• MDR Report Key: 20297195
• Report Number: 2015691-2024-07344
• Device Sequence Number: 8866596
• Product Code: DXE
• UDI-Device Identifier: 00690103043280
• UDI-Public: 00690103043280
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2024

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: 120803F
• 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: 09/09/2024
• Initial Report FDA Received Date: 09/24/2024
• 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
• Patient Sex: Unknown