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

Model Number	140806
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
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 the membrane of this 140806 fogarty corkscrew catheter was torn during thrombectomy in the artificial blood vessel.There were no patient complications reported.
Additional Manufacturer Narrative
A correction is being submitted based on the findings.Per the evaluation, the balloon was found to be intact and the wire was not exposed, therefore this event is no longer reportable.Customer report of ""catheter was torn"" was unable to be confirmed.As received there was no visible damage observed in the catheter body, latex membrane and the spring body.However, the spiral wires were not able to retract and extend when the thumb slide on the handle was moved.The handle was opened and the core wire was found to be completely detached from the thumb slide bushing.When the core wire was pulled directly, the membrane moved in conjunction.No other visible damage was observed from catheter body and membrane.A device history record review was completed and documented that device met all specifications upon distribution.As part of the manufacturing process, 100% of the units go through a functionality inspection per procedure.Part of this inspection includes the verification of coil behavior and membrane integrity by opening and closing the knob 3 times.Based on the available information it cannot be confirmed that this complaint is associated to a manufacturing/design defect.

• Brand Name: FOGARTY CORKSCREW
• Common Device Name: FOGARTY CORKSCREW CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: erika bonilla ; one edwards way; irvine, CA 92614
• MDR Report Key: 20359467
• Report Number: 2015691-2024-07549
• Device Sequence Number: 20653992
• Product Code: DXE
• UDI-Device Identifier: 00690103042412
• UDI-Public: (01)00690103042412(17)250914(11)230616(10)65103664
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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 Expiration Date: 09/14/2025
• Device Model Number: 140806
• Device Lot Number: 65103664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/20/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• 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