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

Model Number 120404FP

Device Problems Material Fragmentation (1261); Inflation Problem (1310)

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

Event Date 07/17/2022

Event Type  malfunction  

Manufacturer Narrative

Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.A device history record review and engineering evaluation have been 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.

Event Description

Per medwatch report mw511051, during a left thigh exploratory surgery for ballistic wound trauma, there were four fogarty arterial embolectomy catheters that were tested on the sterile field and would not maintain balloon inflation.The fifth catheter was used successfully.Upon follow-up with the facility, it was learned that the patient lost a total of 3000 ml of blood and was transfused with 2450 ml of fluid/blood products.The reporter stated that the delay of use of the embolectomy catheter was not a contributing factor in the blood loss.The catheters will not be returned for evaluation as they were discarded.The patient recovered.

Manufacturer Narrative

Our product evaluation lab received one model 120404f embolectomy catheter.The balloon latex appeared deteriorated with multiple cracks and tears evident.Leakage was observed through the tears on the balloon.Both balloon windings were intact.The balloon latex was released from the proximal windings to check the balloon edges at the tears, which 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 the catheter body.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of a balloon issue was confirmed on evaluation.An engineering evaluation has been 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.As part of the manufacturing process controls, 100 percent of the units go through a balloon winding and visual inspection.The units should not have bends, wrinkles, cuts, contamination, stains, deterioration, discoloration, or ripples.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.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• Type of Device: FOGARTY 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 15311828
• MDR Text Key: 304194991
• Report Number: 2015691-2022-07570
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00690103205107
• UDI-Public: (01)00690103205107(17)230531(11)210301(10)63669374
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2022

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 Expiration Date: 05/31/2023
• Device Model Number: 120404FP
• Device Catalogue Number: 120404FP
• Device Lot Number: 63669374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 09/07/2022; 10/13/2022
• Supplement Dates FDA Received: 09/20/2022; 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 67 KG