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

Model Number	140806
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the membrane of the fogarty corkscrew catheter was torn and the wire was exposed during use.After replacing the catheter with a different lot number, the catheter could be used without any problem.Patient demographics were requested but unavailable.The devices were discarded at the hospital due to infection.There were no patient complications reported.Without return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.However, an investigation was initiated to assess for any manufacturing related processes which could be correlated to the lot number.Per the device history record review, the device met all specifications upon distribution.Since a failure mode could not be confirmed, further investigation could not be performed.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.

• Brand Name: FOGARTY ADHERENT CLOT CATHETER
• Common Device Name: CATHETER, EMBOLECTOMY
• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 19060252
• Report Number: 2015691-2024-02662
• Device Sequence Number: 6602988
• Product Code: DXE
• UDI-Device Identifier: 00690103042412
• UDI-Public: (01)00690103042412(17)250528(11)230227(10)64924227
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K901625
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2024

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
• Device Expiration Date: 05/28/2025
• Device Model Number: 140806
• Device Lot Number: 64924227
• 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: 03/18/2024
• Initial Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2023
• 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