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

Model Number 120805FP

Device Problems Degraded (1153); Material Fragmentation (1261)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported that the customer had an incident on (b)(6) 2023, where an embolectomy catheter balloon failed during a procedure.The 1.5 ml of liquid was used as ifu requires and the balloon burst upon use.Fogarty arterial embolectomy catheter, catalog # 120805fp, lot # 64493859.Case was completed using alternative methods.The catheter was not stored in a room where ultraviolet cleaning units are used.There was no allegation of patient injury.

Manufacturer Narrative

Our product evaluation lab received one model 120805f embolectomy catheter.The customer report of balloons failed was confirmed.Balloon latex appeared deteriorated.Multiple cracks and tears were evident on balloon latex.Leakage was observed through the tears on the balloon.Both balloon windings were intact.Balloon latex was released from proximal winding to check balloon edges at the tears.The edges did not appear to match at the tears.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.A capa was initiated for this issue and a product risk assessment was needed.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.A device history record review was completed and documented that device met all specifications upon distribution.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 a part of the monthly review.

Manufacturer Narrative

Our product evaluation lab received one model 120805f embolectomy catheter.The customer report of balloons failed was confirmed.Balloon latex appeared deteriorated.Multiple cracks and tears were evident on balloon latex.Leakage was observed through the tears on the balloon.Both balloon windings were intact.Balloon latex was released from proximal winding to check balloon edges at the tears.The edges did not appear to match at the tears.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.A capa was initiated for this issue and a product risk assessment was needed.An engineering evaluation was performed 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 was completed.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.Corrective actions have been implemented.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.A device history record review was completed and documented that device met all specifications upon distribution.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 a part of the monthly review.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18480120
• MDR Text Key: 332548377
• Report Number: 2015691-2024-00193
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 50690103205225
• UDI-Public: (01)50690103205225(17)241031(11)220802(10)64493859
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

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 Model Number: 120805FP
• Device Lot Number: 64493859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2022
• 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