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 10/10/2014

Event Type  malfunction  

Event Description

It was reported that when testing the balloon with 1.5 ccs of air before insertion of the catheter, the balloon would not deflate.1.5 ccs of saline was then injected in an attempt to deflate the balloon.The balloon eventually deflated.

Manufacturer Narrative

We received one 131f7 catheters with (1) attached monoject 3ml syringe with 1.5 ml limited volume for examination.The balloon inflated concentric for 5 minutes, but was found to have residual liquid inside.Note per the ifu, the balloon should be inflated using 1.5ml co2 or air.Also per the ifu, ¿do not use liquid¿ to inflate the balloon.The balloon failed to deflate with syringe detached.The balloon latex was found to have windows around the central area of the balloon.The inflated balloon was ruptured during examination.All other through lumens were patent without any leakage or occlusion.There was no other visual damage, contamination, or other abnormalities found on the catheter and syringe.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.

• 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: 4238061
• MDR Text Key: 4975263
• Report Number: 2015691-2014-02647
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2016
• Device Model Number: 131F7
• Device Lot Number: 59745876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2014
• Date Manufacturer Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2014
• 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