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 01/20/2015

Event Type  malfunction  

Event Description

It was reported that the balloon did not inflate to the appropriate size before use.The balloon was also difficult to deflate.Additionally, the reporter also stated the balloon inflated eccentrically.It is unknown if the inflation syringe was removed from the gate valve or not at the balloon deflation.It was difficult to deflate the balloon but the balloon deflated.No patient injury was reported.

Manufacturer Narrative

One catheter without any attached components was returned for evaluation in the original opened packaging box.The balloon inflated clear and remained inflated for 5 minutes without leakage.Eccentricity was found to be within specifications measuring 0.035".Balloon deflation was achieved within specifications at 1 second.All through lumens were patent without any leakage or occlusion.No visible damage or inconsistency to the catheter body or balloon was observed.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.Balloon inflation test was performed using lab bd 1 cc syringe with 0.8 cc air.A device history record review was completed and documented that device met all specifications upon distribution.The complaint of inflation difficulty, deflation difficulty and balloon inflated eccentrically 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.

• 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 ; 1 edwards way; irvine, CA 92614 ; 9492504386
• MDR Report Key: 4516554
• MDR Text Key: 5443301
• Report Number: 2015691-2015-00313
• 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
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2016
• Device Model Number: TS258H5F
• Device Lot Number: 59855165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2015
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2014
• 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