MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ THERMODILUTION CATHETER WITH AMC THROMBOSHIELD; SWAN-GANZ CATHETER

Model Number TS258H5F

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2014

Event Type  malfunction  

Event Description

It was reported that "the balloon did not deflate before use although the inflation syringe was taken out from the gate valve.¿ no patient injury was reported.

Manufacturer Narrative

The device evaluation is in progress.A supplemental report will be sent with the investigation results.A device history record review was completed and documented that the device met all specifications upon distribution.

Manufacturer Narrative

One catheter with monoject 0.8 cc limited volume syringe was returned for evaluation.The syringe was detached from the gate valve.The balloon inflated clear, concentric and remained inflated for 5 minutes without leakage.No resistance was felt during injecting air.No visible damage or deterioration to the balloon latex and balloon bonding sites was observed.The balloon deflated within one second with and without the syringe attached.The specification for balloon deflation without a syringe attached is 4 seconds.All through lumens were patent without any leakage or occlusion.No visible damage to the catheter body or returned syringe was observed.Balloon inflation test was performed using returned syringe with 0.8 cc air by holding the balloon under water.Visual examinations were performed under microscope at 10x magnification.Customer report of ¿balloon did not deflate¿ was not confirmed.There was no evidence of a manufacturing nonconformance.It is unknown if procedural factors or device handling may have contributed to the event reported.No further actions will be taken at this time.

• Brand Name: SWAN-GANZ THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• Type of Device: SWAN-GANZ CATHETER
• 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 ; one edwards way; irvine, CA 92614 ; 9492504386
• MDR Report Key: 3754626
• MDR Text Key: 4480739
• Report Number: 2015691-2014-00882
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K812563
• 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: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2015
• Device Model Number: TS258H5F
• Device Lot Number: 59684740
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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