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

Model Number XT245SJ

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The allegation is against 2 models, xt245sj and xt248sj and the exact number of events is unknown.None of the devices are available for return.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.The lot number was not provided thus a device history record was not reviewed.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.

Event Description

For the 4.5 fr pediasat oximetry catheter kits, the physician has an impression that the outer diameter (od) of a dilator is slightly large for the od of 4.5 fr pediasat oximetry catheter.In previous cases, blood leaked from the gap between the catheter and skin after dilation of access vessel.Other than od mismatch between a dilator and a catheter, there was no abnormality or difficulty in devices reported.It is unknown how many cases there have been so far.Exact number of cases or details of individual cases could not be clarified.Exact model number in question was unknown; it was possible the issue occurred in both models, xt245sj and xt248sj.No case with severe complication due to blood loss or intervention including blood transfusion was reported.

• Brand Name: PEDIASAT OXIMETRY CATHETER KIT
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 13374141
• MDR Text Key: 285740314
• Report Number: 2015691-2022-03665
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K053609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: XT245SJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other