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

Model Number	120602F
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the results become available.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.
Event or Problem Description
It was reported that during a thrombectomy procedure, the dr.Was using the 120602f fogarty catheter and the balloon popped.The wire got stuck in the artery.No further details provided.
Additional Manufacturer Narrative
The fogarty catheter was expected to be returned for evaluation but was not returned.Without the 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.It is not known if some procedural factors may have contributed to the event.An engineering evaluation was completed to assess for any manufacturing related processes which could be correlated to the complaint.The suspect unit was not returned for evaluation; therefore a product non-conformance or device failure could not be confirmed.A device history record review was completed and documented that device met all specifications upon distribution.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.
Additional Manufacturer Narrative
Additional information was received that, the date of event occurred on (b)(6) 2024.The balloon was tested prior to insertion.The defective catheter was removed by the surgeon and another catheter was used.There were no additional unplanned procedures.There was no patient injury.
Additional Manufacturer Narrative
It was found that this complaint is a duplicate report of report id: 2015691-2024-08383.A follow up correction is being submitted and the complaint will be voided as the investigation was completed under the complaint associated with report id: 2015691-2024-08383.

• Brand Name: FOGARTY
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco CA 00610
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 20794218
• Report Number: 2015691-2024-09017
• Device Sequence Number: 6764006
• Product Code: DXE
• UDI-Device Identifier: 00690103043273
• UDI-Public: (01)00690103043273(17)260530(11)240229(10)65607068
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/01/2025

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: 05/30/2026
• Device Model Number: 120602F
• Device Lot Number: 65607068
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: 01/10/2025; 02/17/2025; 07/01/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/23/2025; 03/10/2025; 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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