MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR PEDIASAT CENTRAL VENOUS OXIMETRY CATHETER; PEDIASAT CATHETER

Model Number XT358SJ

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review was completed and documented that device met all specifications upon distribution.

Event Description

It was reported that medication leakage was observed from the distal end of the backform of the pediasat catheter on the first day of use.The catheter was exchanged and the problem was solved.No new access site was required.The catheter was cut off and checked by the customer.It is unknown what kind of medicinal solution leaked.Demographic information for the pediatric patient was not available.No blood leakage was observed.No patient complications were reported.

Manufacturer Narrative

Additional information was received that the medicinal solution that leaked was heparinized saline.The patient was a girl, 1 year, 8 months years old.One triple lumen pediasat catheter was returned for evaluation.A non-edwards 10ml syringe was attached at the distal lumen hub.Customer report of leakage issue was not able to be confirmed during evaluation due to returned sample condition.As received into lab, the catheter body was cut in half at the distal end of the backform.It was reported that the catheter was cut off by the customer.Leak test was performed to the sample from hubs to distal end of backform, and no leakage was observed.It was not able to perform leak test to the catheter body side because it was cut off.No visible damage was observed at the catheter tip bond area.No other visible damage was observed on the catheter body during visual examination.Visual examinations were performed under microscope at 10x magnification.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.If a leak in the backform is undetected at routine pre-insertion flushing, the catheter could leak during use and need to be removed/ exchanged for a new one.This could be done over a guidewire with minimal delay in therapy, and would not require a new venous access.These catheters, however, are used in pediatric patients, who have a lower threshold for brief interruptions in therapy or medication loss than adult patients.This results in a higher potential for an injury to occur.Therefore this is a reportable event.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 part of this monthly review.

Manufacturer Narrative

Occurrence date was found to be (b)(6) 2020, not (b)(6) 2020 through the customer¿s memo enclosed with the returned device.

• Brand Name: PEDIASAT CENTRAL VENOUS OXIMETRY CATHETER
• Type of Device: PEDIASAT CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 10446327
• MDR Text Key: 205348053
• Report Number: 2015691-2020-13288
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K053609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2020

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: 10/17/2021
• Device Model Number: XT358SJ
• Device Lot Number: 62544662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 08/26/2020; 08/26/2020
• Supplement Dates FDA Received: 09/18/2020; 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1