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

Model Number 177HF75J

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2014

Event Type  malfunction  

Event Description

It was reported that "the balloon inflated eccentrically at the inflation test before use.The customer inflated the balloon again then the balloon got ruptured." no patient injury was 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 in original opened packaging box was returned for evaluation.No introducer was returned.The balloon was found to be ruptured at the central area of the latex and the ruptured edge was not able to match up.No visible damage to the catheter body or returned syringe was observed.All through lumens were patent without any leakage or occlusion.Visual examinations were performed under microscope at 20x magnification.A device history record review was completed and documented that the device met all specifications upon distribution.Customer report of balloon rupture was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.

• Brand Name: SWAN-GANZ CCO V CCO/CEDV 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: 3656042
• MDR Text Key: 19300782
• Report Number: 2015691-2014-00498
• 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: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2014
• Device Model Number: 177HF75J
• Device Lot Number: 59392167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2014
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Date Manufacturer Received: 02/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2012
• 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