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

Model Number X3820SJD

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

Patient Problem Cardiac Perforation (2513)

Event Date 01/12/2017

Event Type  Injury  

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.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.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.Cardiac perforation is listed as a potential complication in the product instructions for use (ifu).The clinician noted that the patient¿s anatomy as well as procedural factors may have contributed to the event.As no device malfunction was identified at the time of the documentation of this mdr, no corrective actions will be taken at this time.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.

Event Description

It was reported that a (b)(6) year old female patient experienced cardiac perforation during use of a presep oximetry cv catheter.The patient was having aortic valve replacement surgery.The catheter was inserted in the right internal jugular vein with echo guidance.After catheter insertion, the patient went into ventricular fibrillation and blood was observed around the heart via echo.The patient¿s chest was opened and pooling of blood inside the endocardia was confirmed.The endocardia was ¿decorticated¿, then the blood was aspirated and a patch was placed on the cardiac perforation.The avr surgery was restarted.The patient had a history of collagen disease, aortic stenosis, refractory arrhythmias and an implantable defibrillator.The clinician commended that the ¿patient¿s anatomy was fragile as she had collagen disease.Perforation with the guidewire was suspected because no other medical device which could perforate was located inside the heart.It is unlikely that the perforation was caused by the catheter.¿ ¿the patient recovered.¿.

Manufacturer Narrative

One triple lumen presep oximetry catheter was returned for evaluation.A suture loop and box clamp were attached on the catheter body at the 14 to 16cm marker area.The suture was tied to the catheter body between the 16 and 17cm marker.The guidewire was not returned.General evaluation was performed on the returned sample.No visible damage to the catheter was observed.All thru-lumens were found to be patent and did not leak.The ifu states the following regarding cardiac perforation: atrial perforation and subsequent pericardial tamponade have been reported.Preventive measures should include verification of 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.Visual examinations were performed under microscope at 10x magnification.Leak test was performed by pressurizing with air using a 10cc syringe with the catheter submerged in water.Customer report of cardiac perforation issue could not be confirmed during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY KIT
• 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: 6305997
• MDR Text Key: 66656466
• Report Number: 2015691-2017-00280
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

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: X3820SJD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 02/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 46