MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ THERMODILUTION CATHETER; CATHETER, FLOW DIRECTED

Model Number 131F7

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

We received one 131f7 catheter with attached monoject 1.5cc limited volume syringe for examination.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.The balloon deflated within 2 seconds without a syringe attached.As stated in the ifu ¿passively deflate the balloon by removing the syringe from the gate valve¿.The balloon failed to deflate fully with the returned syringe attached.All through lumens were patent without any leakage or occlusion.No visible damage was observed from the catheter body or the returned monoject 1.5cc limited volume syringe.A review of the manufacturing records indicated that the product met specifications upon release.The reported event was not confirmed.Although the cause of the complaint could not be determined, there was no indication of a manufacturing defect noted during the analysis.No actions will be taken at this time.

Event Description

It was reported that the balloon would not deflate during the balloon test.It was specified that the user removed the syringe from the gate valve during deflation and that the balloon was inflated with 1.5 ml of air.Then the user tried to deflate the balloon by pressing it with the fingers and the balloon burst.There was no patient consequence.

• Brand Name: SWAN-GANZ THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• 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: 5207918
• MDR Text Key: 30631522
• Report Number: 2015691-2015-02992
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2017
• Device Model Number: 131F7
• Device Lot Number: 60045229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2015
• 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