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

Model Number 746HF8J

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2015

Event Type  malfunction  

Manufacturer Narrative

One catheter with monoject 1.5 cc limited volume syringe was returned for evaluation in original opened tray.No packaging or introducer was returned.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.Balloon deflation was achieved within specifications at 2 second without the syringe attached.The balloon failed to deflate fully with the returned syringe attached, however; the ifu instructs the user to ¿passively deflate the balloon by removing the syringe from the gate valve.¿ all through lumens were patent without any leakage or occlusion.No visible damage to the catheter body, balloon, or returned syringe was observed.Balloon inflation test was performed using the returned syringe.Visual examination was performed under microscope at 10x magnification and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.The complaint of deflation difficulty could not be confirmed during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.

Event Description

It was reported that the balloon did not deflate easily at the inflation test before use.The plunger of the inflation syringe was pulled and then the balloon deflated.It is unknown if the inflation syringe was removed from the gate valve or not.There were no patient complications reported.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2/VIP 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 ; 1 edwards way; irvine, CA 92614 ; 9492504386
• MDR Report Key: 5085521
• MDR Text Key: 26111810
• Report Number: 2015691-2015-02446
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K934742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2016
• Device Model Number: 746HF8J
• Device Lot Number: 60024624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2015
• Date Manufacturer Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2015
• 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