MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER WITH AMC THROMBOSHIELD; CATHETER, FLOW DIRECTED

Model Number 744HF75

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

It was reported that there was balloon deflation difficulty with the catheter.The error was detected during preparation.The doctor chose not to use the catheter and replaced it with a new catheter that worked correctly.The syringe was not attached to the valve during balloon deflation.The inflation volume was 1.5 ml exactly as it appears in edwards instructions for use.

Manufacturer Narrative

We received one catheter for examination.The syringe was not returned with the catheter.The balloon inflated clear, concentric and remained inflation for 5 minutes without leakage.No resistance was felt during injecting air.No visible damage or deterioration was found from the balloon latex and balloon bonding sites.The balloon deflated in 2 seconds without the syringe attached.All through lumens were patent without any leakage or occlusion.No visible damage was observed from catheter.Per the ifu, passively deflate the balloon by removing the syringe from the gate valve.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.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• 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: 4733506
• MDR Text Key: 21545777
• Report Number: 2015691-2015-00960
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K924452
• 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: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2015
• Device Model Number: 744HF75
• Device Lot Number: 59795915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Date Manufacturer Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2012
• 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