MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHI; SWAN-GANZ CATHETER

Model Number 777HF8J

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2014

Event Type  malfunction  

Event Description

It was reported that "the balloon got ruptured when the balloon was inflated after 2 weeks of use.There were no patient complications reported.

Manufacturer Narrative

The catheter that was returned for evaluation had a ruptured balloon with latex material missing.One catheter with attached monoject 1.5 cc limited volume syringe, 5 three-way stop cocks and pressure tube was returned for evaluation.A non-edwards contamination shield was located between 42 and 101 cm proximal from the catheter tip.No introducer or packaging was returned.The balloon was found to be ruptured at the central area of the balloon latex, approximately 2 mm x 2.5 mm in size.The ruptured edge of the latex appeared to be different shapes and was not able to match up.Note that the ifu states ¿the incidence of complications increases significantly with indwelling periods longer than 72 hours." all through lumens were patent without any leakage or occlusion.No damage or inconsistencies to the catheter body or returned syringe was observed.Balloon inflation test was performed using returned syringe with 1.5 cc air by holding the balloon under water.Visual examination was performed under microscope at 20x magnification with lab scale.A device history record review was completed and documented that the device met all specifications upon distribution.Customer report of balloon rupture issue was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHI
• Type of Device: SWAN-GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 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: 4194196
• MDR Text Key: 21526744
• Report Number: 2015691-2014-02490
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040287
• 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: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2015
• Device Model Number: 777HF8J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2014
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2014
• 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