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

Model Number	140806
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has arrived for evaluation, however, the product evaluation results and completion of the device history record review are pending.Once the results become available a supplemental report will be submitted.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 a part of the monthly review.
Event or Problem Description
It was reported that a wire of the fogarty corkscrew catheter was detached during use.No further information is available at this moment.There were no patient complications reported.
Additional Manufacturer Narrative
Our product evaluation lab received one model# 140806 adherent clot catheter without any attached components.The customer report of a wire of this fogarty corkscrew catheter was detached was confirmed.As received, 2 kinks were observed on catheter body at 15.5 cm and 24 cm proximal from tip.When thumb slide was moved to contracted position, core wire was pulled out from membrane of catheter tip.The latex membrane was intact.No other visible damage was observed from catheter body and membrane.Per the product evaluation results the non-conformance involves a broken wire in the tip of the catheter, however the latex remains intact.There is no potential for the tip to separate in the patient if the latex remains intact.Therefore, this event is no longer reportable.

• Brand Name: FOGARTY CORKSCREW
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 21229613
• Report Number: 2015691-2025-00452
• Device Sequence Number: 15527085
• Product Code: DXE
• UDI-Device Identifier: 00690103042412
• UDI-Public: (01)00690103042412(17)270109(11)241010(10)66012188
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K901625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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: 140806
• Device Lot Number: 66012188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2025
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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