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 Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2014

Event Type  malfunction  

Event Description

It was reported that "resistance against the inflation syringe was lost suddenly when inflating the balloon on the first day of use.There were no problems observed during inflation test or during surgery." the customer commented that the catheter would not have been damaged by other medical products since the catheter was used only for pap or pawp measurement.It is also hard to believe that patient had severe calcification because the patient was only in his 60s.The customer requested for the possible cause of the problem why the balloon suddenly became incapable of inflating after few hours of use.There were no patient complications reported.

Manufacturer Narrative

The catheter that was returned for evaluation had a ruptured balloon with latex material missing.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.No damage or inconsistencies to the catheter body or returned syringe was observed.The balloon was found to be ruptured at the central area of the balloon latex, approximately 1 mm x 2 mm in size.The ruptured edge of the latex appeared to be different shapes and was not able to match up.All through lumens were patent without any leakage or occlusion.Balloon inflation test was performed using returned syringe with 1.5 cc air by holding the balloon under water.Visual examination was performed under microscope at magnification 20x with lab scale.Visual examinations were performed under microscope at 20x magnification.A device history record review was completed and documented that the device met all specifications upon distribution.Customer report of balloon inflation 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 ; 1 edwards way; irvine, CA 92614 ; 9492504386
• MDR Report Key: 3816297
• MDR Text Key: 4452081
• Report Number: 2015691-2014-01170
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2015
• Device Model Number: 777HF8J
• Device Lot Number: 59673905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2014
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2014
• 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