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

Model Number X3820HSJD

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 01/20/2015

Event Type  Injury  

Event Description

It was reported that the catheter came out of the patient¿s body completely during use, even though the catheter was fixed with the box clamp and the suture loop dressing.The suture wing was probably not sutured.It is unknown how long the catheter was used.The catheter was replaced immediately so there were no patient complications.

Manufacturer Narrative

One triple lumen presep catheter with non-edwards injection ports attached at both proximal and distal hubs was returned for evaluation.A suture loop and box clamp were also returned in a non-edwards component detached from catheter.The component was stuck with adhesive tape which was not an edwards dressing.No visible damage to the catheter body was observed.There was no visible indication that the suture wings had been sutured or stretched.The clinician is instructed in the presep ifu that ¿once in position after the guidewire has been removed, secure the catheter by suturing the integral suture wings to the skin.¿ the box clamp and suture loop were removed from the non-edwards component and attached to the returned catheter body.The box clamp and suture loop functioned properly, and did not move or detach from the catheter body.No visible damage to the box clamp or suture loop was noted.All through-lumens were found to be patent without any leakage or occlusion.Visual examinations were performed under microscope at (b)(4) magnification.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Examination of the device did not confirm a product malfunction.No actions will be taken at this time.

• 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 ; 9492504386
• MDR Report Key: 4517003
• MDR Text Key: 18898706
• Report Number: 2015691-2015-00310
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 01/26/2015
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 02/13/2015
• 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