MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHI; SWAN-GANZ CATHETER

Model Number 777HF8J

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

Patient Problems Death (1802); Embolism (1829); Necrosis (1971)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.No actions will be taken at this time.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.The duration of catheterization should be the minimum required by the patient¿s clinical state since the risk of thromboembolic and infectious complications increases with time.The incidence of complications increases significantly with indwelling periods longer than 72 hours.It is unknown if user or procedural factors contributed to this 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.

Event Description

It was reported that a patient had cardiac surgery in (b)(6) 2016.In (b)(6) 2017 a physician contacted edwards lifesciences and stated that the patient had had an embolism.It is unknown when this embolism occurred and where in the body it was located.No additional information was able to be obtained from the physician regarding the patient or incident that was referenced.

Manufacturer Narrative

On (b)(6) 2016, the patient underwent surgery for avr, mvp, tap and maze.On (b)(6), the patient continued treatment in the icu and was extubated.The following day, the patient experienced paralysis in both upper and lower left extremities.Four days later, a positive diagnosis for heparin induced thrombocytopenia (hit), melena, and thrombopenia was confirmed.The patient expired on (b)(6) 2016.Autopsy was performed and the cause of death was found to be intestinal necrosis caused by hit.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHI
• Type of Device: SWAN-GANZ 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: 6347747
• MDR Text Key: 67924891
• Report Number: 2015691-2017-00441
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2017

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: 777HF8J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 02/21/2017
• 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