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

Model Number 120804FP

Device Problem Inflation Problem (1310)

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

Event Date 11/15/2022

Event Type  malfunction  

Event Description

It was reported that the fogarty model 120804f, lot 64311189, balloon would not expand, prior to use.There was no patient injury.This mdr is for sample 3 of 4 of the affected catheters in this instance.

Manufacturer Narrative

Our product evaluation lab received one model 120804f, lot 64311189 embolectomy catheter.The report of the balloon would not expand was confirmed.The balloon latex appeared deteriorated and discolored and there were multiple cracks and tears on the balloon latex.Leakage was observed through the tears on the balloon.The balloon latex was released from proximal windings to check balloon edges at the tears and the edges did not appear to match.Latex deterioration is a condition usually caused by age, excessive exposure to light, atmosphere, or ozone.Appears on the balloon surface as a maze of fine cracks or crazing.The condition may occur in a small area or cover the entire balloon.No other visible damage was observed from catheter body or balloon windings.A device history record review was completed and documented that the device met all specifications upon distribution.The insertion section of the ifu provides important warnings and instructions to verify the electrical continuity and integrity of the device.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Manufacturer Narrative

An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.The storage conditions for these catheters are specified in the ifu.A product risk assessment addresses balloons with fragmentations for embolectomy catheters, and a capa to address this issue is currently in its implementation phase.The capa investigation concluded that the root cause is exposure of latex to ozone, which can happen when the pouch packaged device is stored in rooms with high energy ionizing radiation sources that could generate ozone e.G.Fluoroscopy machines, x ray machines, uv lights, hvac sanitation equipment, etc.As a result, fca 90905 was voluntarily initiated instructing customers to return any product which has been stored in the same room as high energy ionizing radiation sources which emit ozone.The insertion section of the ifu provides important warnings and instructions to verify the electrical continuity and integrity of the device.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• Type of Device: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 16269255
• MDR Text Key: 309159505
• Report Number: 2015691-2023-10451
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

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: 120804FP
• Device Catalogue Number: 120804FP
• Device Lot Number: 64311189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 01/30/2023
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FCA 90905
• Patient Sequence Number: 1