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

Model Number X3820SJD

Device Problem Material Separation (1562)

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

Event Date 03/05/2021

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 the coating material of the guidewire of an edwards oximetry catheter came off before use.It was also reported that the hemostat contained in the kit did not open and close smoothly before use.No further information could be obtained from the customer.The reporter commented that it was unable to identify the guidewire issue visually, but that the j-shaped tip of the guidewire appeared to be different than usual.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One needle holder and one guidewire with holder was returned for evaluation.Packaging and all other components were not returned.Customer report of issue with guidewire was confirmed during evaluation.Damage was found on the j tip area of the returned guidewire.The guidewire coil was found to be damaged and uneven at two locations on the j tip area.No other visible damage to the guidewire was observed.Additionally, the customer report of issue with needle holder was not confirmed.No visible damage was observed from the returned needle holder during visual examination.It was able to interlock the needle holder, and hold a lab needle without any problem.Visual examinations were performed under microscope at 10x magnification.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 instance, damage was found on the j tip area of the returned guidewire.The guidewire coil was found to be damaged and uneven at two locations on the j tip area.In this event, there were no patient complications noted as the issue was found before use.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.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY KIT
• Type of Device: PRESEP CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco CA ; JA
• MDR Report Key: 11572589
• MDR Text Key: 247951699
• Report Number: 2015691-2021-02067
• 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
• Report Date: 04/19/2021

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: 06/26/2022
• Device Model Number: X3820SJD
• Device Lot Number: 63238288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 03/25/2021
• Supplement Dates Manufacturer Received: 04/05/2021
• Supplement Dates FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1