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 06/27/2014

Event Type  malfunction  

Event Description

As reported, the fogarty balloon would not deflate when the syringe was taken off the device.The balloon was inflated with air.The user was able to deflate the balloon with the syringe attached.No complications with patient where reported.

Manufacturer Narrative

We received one model # 744hf75 catheter with attached monoject 3ml syringe with 1.5 ml limited volume for examination.The reported event of ¿deflating the balloon doesn't work when the syringe is taken off the device¿ was not confirmed.The balloon inflated clear, concentric and remained inflation for 5 minutes without leakage.No resistance was felt during injecting air.There was no visible damage or deterioration found from the balloon latex and balloon bonding sites.The balloon deflated within 2 seconds without the syringe attached which was in specification.All through lumens were patent without any leakage or occlusion.There was no visible damage observed from the catheter and syringe.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.A supplemental report will be forthcoming when the device history record is received.

Manufacturer Narrative

A review of the manufacturing records indicated that the product met specifications upon release.

• 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: 3958954
• MDR Text Key: 4608949
• Report Number: 2015691-2014-01702
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup
• Report Date: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2015
• Device Model Number: 744HF75
• Device Lot Number: 59725270R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2014
• 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