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

Model Number 120805FP

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Event Description

It was reported that the balloon of an embolectomy catheter appeared to be dry rotted.Issue was noticed during device prep and prior to surgery.Staff commented that the catheters were packaged in the new cover and not expired.There were no patient injuries reported.The device was returned.Per product evaluation, the reported event of balloon issue 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.No other visible damage was observed from catheter body.A device history record review was completed and documented that device met all specifications upon distribution.A supplemental report will be forthcoming when the investigation is completed.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

An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.The storage conditions for these catheters are specified in the ifua capa was previously initiated and used as reference in the evaluation as it addresses the "balloon - latex deterioration" failure for the embolectomy models with a vascupouch packaging.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.The storage conditions for these catheters are specified in the ifu.The capa resulted into a voluntary field correction action that instructed customers to return any product which has been stored in the same room as high energy ionizing radiation sources which emit ozone.

• 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: katheryn richards ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 19188383
• MDR Text Key: 341681891
• Report Number: 2015691-2024-03169
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00690103205220
• UDI-Public: (01)00690103205220(17)240607(11)220309(10)64252694
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2024

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 Model Number: 120805FP
• Device Lot Number: 64252694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2022
• 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