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

Model Number 777F8

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Encephalopathy (1833); Hemorrhage/Bleeding (1888); Injury (2348); Cardiac Perforation (2513)

Event Date 06/15/2018

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, nor could a root cause or potential contributing factors be identified.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.In this instance, there was no allegation of product malfunction.The serious injury occurred because the clinician sewed the catheter to the heart.There was no allegation of product malfunction by the reporting clinician.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 following induction of general anesthesia, a swan-ganz catheter was inserted for surgical aortic valve replacement.After surgery, fluoroscopy showed the catheter tip was positioned incorrectly.When the catheter was slowly removed, massive bleeding was observed from the drain.The chest was opened immediately, and it was found that the right atrium free wall was vertically torn from proximal right atrial appendage to inferior vena cava.The injury was repaired.After cardiopulmonary bypass (cpb) was introduced, the superior vena cava was incised, and the catheter was removed.A suture was found on the catheter at approximately 5 cm from the catheter tip and tissue from the right atrium wall was also adhered.It was determined that the catheter was stitched to the right atrium and the injury was caused when the catheter was removed.The patient was closely monitored in the icu.Occurrence of hypoxic encephalopathy was a concerned since there was an absence of blood flow to the brain and organs during surgery; therefore, hypothermia therapy was initiated.On the following day, sudden re-bleeding occurred.Injury of the superior vena cava was found, and it was repaired.Brain damage due to hypoxic encephalopathy has been broadened and there is less chance of recovery.The customer reported there was no device malfunction.The device was discarded at the hospital.

Manufacturer Narrative

Additional information was obtained on (b)(6) 2018 that the patient expired after approximately four months from the reported event of a (b)(4) catheter mistakenly being stitched to the right atrium of the patient.There was no allegation that a device malfunction contributed to the death.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ
• Manufacturer (Section D): EDWARDS LIFESCIENCES,PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 7743300
• MDR Text Key: 115899243
• Report Number: 2015691-2018-03140
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2018

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: 777F8
• Device Catalogue Number: 777F8
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 11/26/2018; 07/23/2020
• Supplement Dates FDA Received: 12/04/2018; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Other; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 52