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

Model Number	140806
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One fogarty corkscrew catheter was received by our product evaluation laboratory for a full examination.The report of "guidewire failed to pass through the catheter" was unable to be confirmed.However, spiral cable was exposed through a tear in the latex membrane.Edges of the torn region appeared to match up.There was no visible damage observed to the catheter body.It was able to move the thumb slide on the handle forwards and backwards.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.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.
Event or Problem Description
As reported, during use in patient of this fogarty corkscrew catheter, guidewire failed to pass through the catheter.There was no allegation of patient injury.The device was received for evaluation.As per evaluation results, spiral cable was exposed through a tear in the latex membrane.
Additional Manufacturer Narrative
As per further clarification the section b5 was updated to "as reported, during use in patient, this fogarty corkscrew catheter wire was coiled and twisted.There was no allegation of patient injury.The device was received for evaluation and the spiral cable was exposed through a tear in the latex membrane." added information to section h6 (type of investigation).Updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).Additionally, the product evaluation was updated to: the report of wire was coiled and twisted was confirmed.Spiral cable was exposed through a tear of approximately 4 mm in length in the latex membrane.The exposed wire appeared twisted and not in its original alignment.Edges of the torn region appeared to match up.There was no visible damage observed to the catheter body.It was possible to move the thumb slide on the handle forwards and backwards.As part of the manufacturing process, a visual inspection is performed to the catheter for general appearance, length of the tube, diameter of the bonding and spiral coil verification in closed position and an inspection of the functionality of the handler is performed to verify the behavior of the coils, spiral and latex membrane integrity.In addition, in the ifu it is indicated the following: "to minimize the risk of vessel or membrane damage, do not exceed the maximum recommended pull force" and "exposure to the atmosphere, handling during insertion, and plaque and other deposits within the blood vessel may cause latex membrane degradation".Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.
Event or Problem Description
As reported, during use in patient, this fogarty corkscrew catheter wire was coiled and twisted.There was no allegation of patient injury.The device was received for evaluation and the spiral cable was exposed through a tear in the latex membrane.

• Brand Name: FOGARTY CORKSCREW CATHETER
• 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, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 23508990
• Report Number: 2015691-2025-09156
• Device Sequence Number: 9666605
• 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: K233619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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: 09/14/2025
• Device Model Number: 140806
• Device Lot Number: 65103664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 11/19/2025
• 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