MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ VIP+ TRI-LUMEN INFUSION THERMODILUTION CATHETER WITH AMC THROMBOSHIELD; CATHETER, FLOW DIRECTED

Model Number 834HF75

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2014

Event Type  malfunction  

Event Description

While testing swan ganz balloon prior to insertion it was noted that the swan ganz balloon would not deflate.The staff was unsure what practice was used to passively deflate.

Manufacturer Narrative

We received one model# 834hf75 catheter for examination.The balloon inflated clear, concentric and remained inflation for 5 minutes without leakage.There was no resistance felt during the injection of air.There was no visible damage or deterioration found from the balloon latex and balloon bonding sites.The balloon deflated within 1 sec.With/without the syringe attached which is in specification.All through lumens were patent without any leakage or occlusion.In addition, there was no visible damage observed from the catheter.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.

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 VIP+ TRI-LUMEN INFUSION THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• 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 selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 3845221
• MDR Text Key: 4682895
• Report Number: 2015691-2014-01281
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K810352
• 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: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2015
• Device Model Number: 834HF75
• Device Lot Number: 59654629
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2013
• 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