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

Model Number 774HF75J

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2016

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and two three-way stopcocks was returned for evaluation.A non-edwards introducer with non-edwards contamination shield was located on the catheter body between 7 cm and 98 cm proximal from the catheter tip.No packaging was returned.As received, blood was observed from inside the attached non-edwards introducer tube, under the balloon latex, and inside the gate valve.The attached non-edwards introducer and non-edwards contamination shield were removed for further evaluation.Two punctures, were found on the catheter body at 5.5 cm proximal from the catheter tip.The punctures measured, <0.5mm long and <0.5 mm long, respectively and were located on the opposite side of each other.The punctures entered into the distal lumen and balloon inflation lumen.The proximal injectate lumen was patent without any leakage or occlusion.The balloon did not inflate due to clotted blood occlusion.No visible damage to the balloon or returned syringe was observed.Balloon inflation test was performed using lab syringe with 1.5 cc air.Visual examination was performed under microscope at magnification 20x and with the unaided eyes.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Customer report of ¿the catheter could not wedge in pulmonary artery¿ could not be confirmed during evaluation, however, blood leakage issue was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.

Event Description

It was reported that the catheter could not wedge in the pulmonary artery during aortic valve replacement during open heart surgery.The catheter was pulled back to the superior vena cava and then re-advanced to the pulmonary artery visually.When the patient was moved after surgery, a small amount of blood was observed in the inflation syringe.There were no patient complications reported by the customer.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• 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: 5855355
• MDR Text Key: 51454630
• Report Number: 2015691-2016-02459
• 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: Other
• Type of Report: Initial
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 774HF75J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Date Manufacturer Received: 07/14/2016
• 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