MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY ARTERIAL EMBOLECTOMY CATHETER WITH GATE VALVE; CATHETER, EMBOLECTOMY

Model Number	12TLW804F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during use in patient, this fogarty embolectomy catheter guidewire did not pass through the catheter, despite having the right size.There was no allegation of patient injury.As per device evaluation results, the catheter body was found broken into two pieces.Patient demographics unable to be obtained.
Additional Manufacturer Narrative
One fogarty embolectomy catheter was received by our product evaluation laboratory for a full examination.The report of "guidewire not passing through the catheter" was unable to be confirmed.Catheter body was broken.Cross surface of broken section appeared uneven and rough.The catheter body appeared to match at the broken region.No other visible damage was observed from catheter body.The returned stylet was passed from tip to hub and from hub to tip and resistance was not felt.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.
Additional Manufacturer Narrative
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.Based on the available information it cannot be confirmed that this complaint is associated to a manufacturing or design defect.As part of the manufacturing process, the units go through a final visual inspection for catheter tube integrity and leaks inspection.The ifu was reviewed and it indicates: "balloon rupture and catheter separation as a result of excessive pull force applied to remove adherent material are the most frequent causes of reported failures." and "to minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation and pull force for each size catheter".

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER WITH GATE VALVE
• 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 ; 9492503939
• MDR Report Key: 20010965
• Report Number: 2015691-2024-06204
• Device Sequence Number: 15254328
• Product Code: DXE
• UDI-Device Identifier: 00690103043518
• UDI-Public: (01)00690103043518(17)250319(11)221219(10)64727956
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233820
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: 03/19/2025
• Device Model Number: 12TLW804F
• Device Lot Number: 64727956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• 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: 07/26/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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