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

Model Number 12TLW405F35

Device Problems Burst Container or Vessel (1074); Material Rupture (1546)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

As reported, when testing this fogarty embolectomy catheter, the balloon leaked saline.There is no allegation of patient injury.The device was available for evaluation.As per product evaluation, it was found that the balloon was ruptured and the balloon edges did not match up.

Manufacturer Narrative

One fogarty embolectomy catheter was received by our product evaluation laboratory for a full examination.The balloon was found to be ruptured and distal ruptured edge was inverted to distal side.After distal ruptured edge was returned to original position, the ruptured edges did not appear to match at the ruptured location.Per the ifu "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.Through lumen was patent without any leakage or occlusion.No other visible damage or abnormality was observed from catheter body, windings and returned syringe.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.

Manufacturer Narrative

Added information to section h6 (type of investigation) updated section h6 (device code), h6 (investigation findings) and h6 (investigations conclusions).As part of the manufacturing process, the units go through a balloon inspection process and a final inspection.Specification for catheters indicate that the deterioration is a condition usually caused by age, excessive exposure to light, atmosphere, or ozone that appears on the balloon surface as a maze of fine cracks or crazing.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18985094
• MDR Text Key: 338663802
• Report Number: 2015691-2024-02342
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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
• Device Operator: Health Professional
• Device Model Number: 12TLW405F35
• Device Lot Number: 65053958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2023
• 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