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

Model Number X3820SJD

Device Problems Difficult to Insert (1316); Failure to Advance (2524)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2020

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 for both lots and documented that the device met all specifications upon distribution.

Event Description

It was reported that on the first day of use of a presep catheter the guidewire did not pass through the catheter needle.The guidewire was removed together with the catheter needle and another device was inserted from a new insertion site.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One guidewire with its holder and one metal needle was returned for evaluation.Packaging and all other components were not returned.Returned components appeared to be a 0.032" guidewire and 18ga x 1 1/2" metal needle, when compared to lab samples of packaging assembly for model x3820sjd.As received, the guidewire was stuck in the metal needle, and the needle tip was located at approximately 3cm from the j-tip.The guidewire was removed from the metal needle and brown material was observed on the guidewire where metal needle had covered the guidewire.The brown material was stuck on the guidewire but was able to be removed from the guidewire during evaluation.Upon removal of the material, the returned guidewire was able to be passed through the metal needle without problem.The material was removed and sent to chemistry for ir spectrum testing.The ir spectrum of the brown material was consistent with that of zein.Guidewire passage test was performed using returned guidewire and needle.Visual examinations were performed under microscope at 10x magnification.Customer report of guidewire insertion issue with needle was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.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, the patient required a new stick during the procedure to insert a new access device and catheter, 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.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY SET
• Type of Device: PRESEP CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 9954018
• MDR Text Key: 195017930
• Report Number: 2015691-2020-11445
• 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: 03/24/2020

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: 04/23/2021
• Device Model Number: X3820SJD
• Device Lot Number: 62452814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 05/01/2020; 07/23/2020
• Supplement Dates FDA Received: 05/18/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1