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

Model Number 120804FP

Device Problem Degraded (1153)

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

Event Type  malfunction  

Event Description

It was reported that during preparation for a case, the balloon from a 120804fp fogarty embolectomy catheter was leaking.No patient invovlement.The device is available for return.

Manufacturer Narrative

Our product evaluation lab received one 120804f.Report of leaking was confirmed.The balloon latex appeared deteriorated.Multiple cracks and tears were 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 the distal winding to check balloon edges at the tears and the edges did not appear to match.Per ifu, latex deterioration is a condition usually caused by age, excessive exposure to light, atmosphere, or ozone.It 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 device history record review was completed and documented that the device met all specifications upon distribution.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 was performed to address balloons with latex fragmentations for embolectomy catheters, and a capa to address balloon deterioration.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.As a corrective action, the "butata" packaging was reinstituted.Units with the new packaging were released starting mid-august 2023.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.

• Brand Name: FOGARTY 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 richards ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18665021
• MDR Text Key: 334885623
• Report Number: 2015691-2024-00829
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/08/2024

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: 64320984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2022
• 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