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

Model Number 12TLW805F35

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

It was further informed that the device was not available for evaluation since it was discarded at hospital due to being exposed to hepatitis b.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.Based on further investigation at the manufacturing site, balloon leakage could have potentially caused the pressure values to be unstable when connected to a device to measure the pressure.However, a definite root cause could not be established since the affected unit was not returned for evaluation.As part of the manufacturing process the units go through balloon and winding leak inspection process.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.Per the ifu, "the thru-lumen embolectomy catheter should not be used in the venous system".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 Description

As reported, during use in patient, the balloon of this fogarty catheter leaked, causing that the device measuring wedged hepatic vein pressures (whvp) provided unstable intraoperative values.The pressure monitoring device was connected to the fogarty catheter.Then, the catheter was withdrawn and balloon inflated to confirm the balloon leakage.The unstable pressure measurements did not affect patient treatment.The catheter had been tested prior to use and it worked properly.There was no allegation of patient injury.The device was not available for evaluation.

• Brand Name: FOGARTY CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): 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: 13019611
• MDR Text Key: 282938383
• Report Number: 2015691-2021-06868
• 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: 12/16/2021

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
• 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
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/16/2021
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 76 KG