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 Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is in progress.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.

Event Description

It was reported that blood was aspirated into the inflation syringe which was connected to the balloon inflation lumen during use.After the blood was aspirated, the customer inflated the balloon inside the patient without any issues.At some point in the procedure the balloon ruptured.It is unknown at what point the balloon rupture happened.A kink was found on the catheter at 11- 12cm from the catheter tip located at the joint of the catheter and the thermal filament.The customer suspected the leakage is related to the kink.Although there was blood leakage observed, there were no patient complications reported by the customer.

Manufacturer Narrative

Additional information and correction: it was reported that a patient undergoing cardiovascular surgery had a swan ganz catheter placed via left internal jugular vein.The balloon tested normally pre-insertion.Upon insertion, the customer had difficulty advancing the catheter.After multiple attempts, the customer pulled the plunger of the inflation syringe and blood was aspirated.The catheter was removed from the patient with a balloon rupture being noted.The customer thought the rupture of the balloon was from when the catheter was removed.No patient complications were reported.One catheter with attached monoject 1.5 cc limited volume syringe and 3 three-way stop cocks was returned for evaluation.No introducer or packaging was returned.Customer report of ¿balloon rupture¿ was confirmed.As received a kink was observed at 11cm to 12cm from the catheter tip.Blood was confirmed in the attached monoject syringe as received in the decontamination lab.Balloon inflation lumen was occluded.Catheter body was kinked at 11 cm, 12 cm, and 86 cm proximal from the catheter tip.Balloon was found to be ruptured around the central area of the balloon latex and the central area of the balloon latex was missing.All through lumens were patent without any leakage or occlusion.No visible damage to the returned syringe was observed.Further examination confirmed balloon rupture and the inflation lumen was found fully occluded with blood.The occlusion was not able to be cleared.An examination of the catheter body was performed at 10x magnification and no punctures or tears to the catheter body with the exception of the 3 kinks were observed.The thermal filament cover was found to be loose indicating some stretch to the catheter body.The catheter passed freely through a 9f introflex introducer which is the required size per the ifu.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examinations were performed under microscope at 20x magnification and with the unaided eyes.The customer report 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.

• 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 ; one edwards way; irvine, CA 92614 ; 9492504386
• MDR Report Key: 5095769
• MDR Text Key: 26477072
• Report Number: 2015691-2015-02508
• 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: Followup
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777HF8J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2015
• 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