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

Model Number X3820HSJD

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2016

Event Type  malfunction  

Manufacturer Narrative

One triple lumen presep catheter was returned for evaluation.Box clamp and suture loop were attached on the catheter body at 13 to 15cm marker.Stopcocks were attached at the lumen hubs.A non-edwards 10ml syringe, with approximately 4.5ml clear solution inside, was returned detached from the catheter.Suture threads were observed at box clamp and suture loop.Sutures were not observed at the suture wings; however, adhesive residues and indentations were observed from the suture wings which may indicate the suture wings were fixed to the patient¿s skin with adhesive tape.The suture wings appeared to have been stretched.The ifu instructs the user to secure the catheter by suturing the integral suture wings to the skin once in position after the guidewire has been removed, and if desired, the optional suture loop/box clamp can be placed on the catheter and sutured to the skin.No other visible defect or damage to the catheter body or attached components was observed.All through-lumens were found to be patent without any leakage or occlusion.The box clamp and suture loop appeared properly attached on the catheter body, and did not move or detach from the catheter body during evaluation.Visual examinations were performed under microscope at 10x magnification.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.No product malfunction is identified.No actions will be taken at this time.

Event Description

It was reported that an unknown medicinal solution was infused subcutaneously during use of a presep catheter.The catheter was inserted 13cm from the tip from the right subclavian vein and fixed by suturing the box clamp and suture loop.Blood was aspirated immediately after insertion.The customer commented that the problem may not have been a product related issue, but suspected the catheter may have moved backward.No further information was able to be obtained.There were no patient complications reported.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5544960
• MDR Text Key: 42499732
• Report Number: 2015691-2016-01078
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: X3820HSJD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 04/04/2016
• 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