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

Model Number 12TLW805F35

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2021

Event Type  malfunction  

Event Description

As reported, during use of this fogarty catheter (medwatch # 11392) connected to a dpt through an extension tubing to block the vessel and measure hepatic venous pressure gradient (hvpg) for diagnostic purpose, the balloon leaked; it allowed blood flow, what caused unstable values.Replacing the fogarty for a new one and keeping the dpt but fogarty balloon leaked and same issue occurred again (medwatch # 11393).Using a third fogarty the issue was solved.The catheters had been tested prior to use and they worked properly.There was no allegation of patient injury and patient diagnose was not affected.The devices were not available for evaluation.

Manufacturer Narrative

It was further informed that the device was not available for evaluation since it was exposed to infectious disease.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.Nevertheless, images were provided for review.As per image evaluation, two pictures showed a catheter, balloon appeared to be in good condition.From one image, blood residues were visible in the balloon, reported model number could be seen on the catheter.Customer report of balloon leakage could not be confirmed from provided pictures.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 further engineering investigation, balloon/winding leak inspection process is performed to the units as part of the manufacturing process.As per ifu: "the thru-lumen embolectomy catheter should not be used outside the arterial system or for endarterectomy procedures" and "the thru-lumen embolectomy catheter should not be used in venous systems." 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.

• Brand Name: FOGARTY EMBOLECTOMY CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 13281907
• MDR Text Key: 285000145
• Report Number: 2015691-2022-03437
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K193379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2023
• Device Model Number: 12TLW805F35
• Device Catalogue Number: 12TLW805F35
• Device Lot Number: 63843848
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 70 KG