MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR PEDIASAT OXIMETRY CATHETER; CATHETER, OXIMETER, FIBER-OPTIC

Model Number XT358SP

Device Problem Leak/Splash (1354)

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

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.

Event Description

It was reported that during use in a child, the pediasat catheter had a leak at the backform.No blood leakage occurred.There was no allegation of patient injury.The device was available for evaluation.Patient demographics were unable to be obtained.

Manufacturer Narrative

Further information was obtained from the anesthesiologist.One lumen of the pediasat central venous catheter was used for pressure measurement.A second lumen was used for inotropic medication on a pump.There was no problem with insertion of the catheter and no other difficulties noted.Based on the evaluation performed of the pediasat central venous catheter leak at the backform, a potential root cause may be associated to the manufacturing process.A capa was opened to further investigate and a product risk assessment was initiated to assess compliance and heath risk.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

One oximetry catheter was returned for examination.The reported event of leakage issue was confirmed.Leakage was confirmed at the junction between the distal extension tube and the backform when pressurized from the medial or proximal hub.Another leakage was also found at the junction between the catheter body and the backform when pressurized from the distal extension tube.A cut down was performed on the backform and blood was visible in the backform.The distal and optical extension tubes were found to be inserted 0.464" and 0.411" into the backform respectively.The distal extension tube had entered the proximal lumen while the optical extension tube had entered both medial and proximal lumens.The lengths of the extension tubes in the backform were out of specification.In addition, gaps were found between the distal, proximal extension tubes, catheter body and the backform materials.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.In this case, leakage occurred in a pediatric patient, who would have a lower threshold for brief interruptions in therapy or minor amounts of bleeding than an adult patient.This results in a higher potential for an injury to occur.

• Brand Name: PEDIASAT OXIMETRY CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 11633884
• MDR Text Key: 244878875
• Report Number: 2015691-2021-02328
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2021
• Device Model Number: XT358SP
• Device Catalogue Number: XT358SP
• Device Lot Number: 62685542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1