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

Model Number X3820S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the 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 this monthly review.No corrective or preventative actions are required at this time.A review of the manufacturing records indicated that the product met specifications upon release.The ifu for the product contains the following warning: ¿positioning the distal tip of the catheter in the right atrium or ventricle is not recommended.¿ atrial perforation and subsequent pericardial tamponade have been reported.Preventive measures should include verification of the catheter tip position by chest x-ray film and 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.No description of the patient¿s anatomy was provided; therefore, it cannot be determined if significant tortuosity or tissue fragility was present.

Event Description

During use of this presep catheter, after extracorporeal circulation was initiated, it was found upon examination of the cardiac walls that there was a perforation of the right atrium by the catheter.The catheter was repositioned by the surgeon and a patch was placed at the perforation site.No patient consequences were reported, as the perforation occurred while the patient was on extracorporeal circulation.Inquired of patient demographics, unable to be obtained.

Manufacturer Narrative

We received one presep triple lumen 20cm catheter without the packaging for examination.The reported event of "perforation of the right atrium" could not be confirmed.The catheter was examined for any damage to the extension tube's ,catheter body and soft tip and there was no damage observed.Leak testing was performed on all through lumens and no leakage or occlusion were observed.The catheter passed in-vitro calibration on the vigilance ii monitor.Per the ifu" atrial perforation and subsequent pericardial tamponade have been reported.Preventive measures should include verification of the catheter tip position by a chest x-ray film and 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." the reported event was not confirmed.Although the cause of the complaint could not be determined, there was no indication of a manufacturing defect noted during the analysis.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.No corrective or preventative actions are required at this time.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY SET
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• 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: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 6251187
• MDR Text Key: 64795577
• Report Number: 2015691-2017-00092
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 12/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2017
• Device Model Number: X3820S
• Device Lot Number: 60218629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2015
• 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 Outcome(s): Required Intervention