MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER; SWAN-GANZ CATHETER

Model Number 096F6J

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2015

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.0 cc limited volume syringe was returned for evaluation.The balloon inflated clear, concentric and remained inflated for 5 minutes without leakage.No resistance was felt during injecting air.No visible damage to the balloon latex or balloon bonding sites was found.Balloon deflation was achieved within specifications at 1 second without the syringe attached and at 4 seconds with the syringe attached.All through lumens were patent without any leakage or occlusion.No visible damage to the catheter body or returned syringe was observed.Visual examination was performed under microscope at 10x magnification and with the unaided eyes.Balloon inflation test was performed using returned syringe with 1.0 cc air.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 clinician was unable to deflate the balloon before use.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 TRUE SIZE THERMODILUTION CATHETER
• 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: 5012010
• MDR Text Key: 23397655
• Report Number: 2015691-2015-02109
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2017
• Device Model Number: 096F6J
• Device Lot Number: 60012431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2015
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2015
• 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