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 09/17/2015

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 leakage was observed from the om-2 cable connection after the catheter was removed from the patient on the first day of use.Blood was observed inside the balloon when the balloon was inflated.The catheter was used for cardiac surgery but the detail of the surgery is unknown.Blood leakage was not noted during use.There were no patient complications reported by the customer.

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe, three manifolds with pressure tubes and four three-way stop cocks were returned for evaluation.A non-edwards contamination shield with non-edwards 9fr introducer was located on the catheter body between 37 cm and 89.5 cm proximal from the catheter tip.No packaging was returned.Blood was observed from the optical module connector and under the balloon latex.The attached non-edwards contamination shield and introducer were removed for evaluation.Two punctures, approximately 0.5 mm long and 1 mm long, were found on the catheter body at 28.5 cm proximal from the catheter tip.The punctures entered into the distal injectate, proximal injectate, optical fiber, and balloon inflation lumens.The proximal infusion lumen was patent without any leakage or occlusion.The balloon did not inflate due to leakage from the punctures.Blood was occluded inside the balloon inflation lumen between the location of the punctures and the catheter tip.No visible damage to the balloon or returned syringe was observed.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.Customer report of blood leakage issue was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.

• 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: 5148533
• MDR Text Key: 28258936
• Report Number: 2015691-2015-02734
• 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: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2015
• 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