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 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.Lot number was not provided; therefore, review of the manufacturing records could not be completed.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.It is unknown whether user or procedural factors contributed to the stated 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.

Event Description

It was reported that the leakage (not blood) occurred from the backform of the pediasat catheter.There was no allegation of patient injury.The devices were not available for evaluation as they were discarded at the hosptial.No other specific details could be provided, as the event occurred some time ago and the report was obtained during discussion of another event.

Manufacturer Narrative

Although this complaint was not confirmed by a non-conformance as the product was not returned for evaluation, another complaint with a similar system of interlumen leak came from the same reporter.Therefore, this complaint is part of a pra and capa to investigate interlumen leakage.

• 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: 11664090
• MDR Text Key: 248854883
• Report Number: 2015691-2021-02448
• 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
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XT358SP
• Device Catalogue Number: XT358SP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1