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

Model Number X3820HSJD

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Perforation of Vessels (2135)

Event Date 05/14/2014

Event Type  Injury  

Event Description

It was reported that the ¿superior vena cava was injured during use in icu.The catheter was inserted in the left internal jugular vein.The customer suspects that the problem occurred due to the catheter body touched the vessel and it was not caused during insertion.There were no patient complications." three days after the surgery, the customer found that the infusion solution was leaking outside the vessel.X-ray was taken and the tip of the catheter was found to be located outside of the vessel.The catheter was removed; the vessel was not sutured.No abnormalities were observed.Duration of hospitalization was extended, but the patient recovered uneventfully.The physician thought the problem was related to the thickness of the patient¿s vessel due to her advanced age.

Manufacturer Narrative

The device was discarded at the hospital.Vessel perforation is listed in the instructions for use as a potential complication associated with the use of the presep central venous oximetry catheter.As noted in the ifu: complications: under vessel perforation - venous perforation and necrosis of the wall of the vein which can lead to perforation, due to a malpositioned catheter, have been reported.Preventive measures should include verification of the catheter tip position by chest x-ray film, noting insertion depth immediately following insertion.Ideally, the catheter tip should be positioned parallel to the vessel wall and no farther than the junction of the superior vena cava and right atrium.Warning: if there is any doubt that the catheter tip may not be intravascular, further steps should be taken to identify the exact location of the catheter tip.Also ¿precaution: the incident of complications increases significantly with indwelling periods longer than 72 hours.¿ without the return of the product, it is not possible to determine if damages or defects existed on the product.It could not be determined if any clinical or procedural factors may have contributed to the event.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: 3870682
• MDR Text Key: 16451595
• Report Number: 2015691-2014-01373
• 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: 05/14/2014

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?: No
• Initial Date Manufacturer Received: 05/14/2014
• Initial Date FDA Received: 06/12/2014
• 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 Age: 80
• Patient Weight: 33