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

Model Number 120804FP

Device Problem Material Fragmentation (1261)

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

Event Date 02/13/2024

Event Type  malfunction  

Event Description

It was reported that when opened this 120804fp fogarty catheter was found to have the balloon popped.There was no patient injury.Our product lab received one 120804f catheter.The reported issue of the balloon popped was confirmed.The balloon latex appeared deteriorated.There were multiple cracks and tears evident on the balloon latex.Leakage was observed through the tears on the balloon.Both balloon windings were intact.The balloon latex was released from proximal winding to check the 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 the catheter body.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 corrective and preventive actions (capa) was created to address this issue.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.

• 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 PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 19076492
• MDR Text Key: 340568390
• Report Number: 2015691-2024-02728
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00690103205213
• UDI-Public: (01)00690103205213(17)241019(11)220721(10)64469758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMEN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/09/2024

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: 120804FP
• Device Lot Number: 64469758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 90905
• Patient Sequence Number: 1