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

Model Number 744F75

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2014

Event Type  malfunction  

Manufacturer Narrative

We received one 744f75 catheters with (1) attached monoject 3ml syringe with 1.5 ml limited volume for examination.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 within 1 second without the syringe attached.All through lumens were patent without any leakage or occlusion.No visible damage was observed from the catheter and returned 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.

Event Description

It was reported that the balloon would not deflate.No information at this time if the staff deflated with the syringe on or off.

Manufacturer Narrative

The device evaluation is anticipated.However the complaint could not be confirmed without the completion of the product evaluation.A supplemental report will be sent when the investigation is complete.A review of the manufacturing records indicated that the product met specifications upon release.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2 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 selwaski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4143841
• MDR Text Key: 15643459
• Report Number: 2015691-2014-02321
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2015
• Device Model Number: 744F75
• Device Lot Number: 59573998
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2013
• 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