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

Model Number	12TLW405F35
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and an evaluation was completed.The reported issue was confirmed.The catheter balloon was unable to inflate with air.Occlusion was felt in the inflation lumen.Resistance was felt when inflating the balloon with distilled water.The balloon could not be deflated completely after 15 seconds by pulling back on the syringe plunger.The catheter body appeared reduced near proximal balloon windings.Cut down was performed on the catheter body to locate occlusion.Balloon inflation lumen was found to be collapsed near the proximal windings.The syringe plunger was received damaged.The balloon latex, bushings and windings were intact.The thru lumen was patent without any leakage or occlusion.No visible damage was observed from catheter body.An engineering task has been assigned for further investigation.The device history record review was completed and all manufacturing inspections passed with no non conformances.
Event or Problem Description
It was reported that there was a failure with the fogarty thru lumen embolectomy catheter, during use.The balloon stopped inflating and deflating.There was no medical intervention.The balloon was removed successfully, however, there was difficulty with deflation.Attempts were made for additional information, but there is no additional information available.There was no patient harm or injury.
Additional Manufacturer Narrative
The engineering evaluation was completed.The root cause was determined to be manufacturing, associated with the collapse of the balloon inflation lumen.The instructions for use ifu instructs the user that the catheter should be inspected with the balloon inflated during purging.In addition, as part the manufacturing process, 100 percent of the units are inspected.A product risk assessment was completed and no unreasonable risks were identified.A capa was opened to assess for any corrective actions required for this issue.Corrective actions were implemented to address manufacturing non-conformance.

• Brand Name: FOGARTY THRU LUMEN EMBOLECTOMY CATHETER
• Common Device Name: FOGARTY CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk km 1.4; anasco, puerto rico
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk km 1.4; anasco, puerto rico
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18942738
• Report Number: 2015691-2024-02143
• Device Sequence Number: 20884034
• Product Code: DXE
• UDI-Device Identifier: 00690103043488
• UDI-Public: (01)00690103043488(17)260429(11)240129(10)65443893
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K892410
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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: 04/29/2026
• Device Model Number: 12TLW405F35
• Device Lot Number: 65443893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• 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: 02/28/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• 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