MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR 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 12/18/2014

Event Type  malfunction  

Event Description

It was reported that the balloon was ruptured on the first day of use.No balloon remnants remained in the patient¿s body.There were no patient complications noted.

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and 2 three-way stop cocks was returned for evaluation with original packaging box.No introducer was returned.The balloon was found to be ruptured at the central area around the circumference.The distal side of the balloon was partially inverted to the catheter tip.After pulling the balloon back to the proximal side, the ruptured edges of latex appeared to be different shapes and were not able to match up.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 20x magnification and unaided eye.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, 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: 4481202
• MDR Text Key: 18290559
• Report Number: 2015691-2015-00223
• 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: 12/22/2014

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: 02/06/2015
• Device Model Number: 777HF8J
• Device Lot Number: 59825695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2015
• Initial Date Manufacturer Received: 12/22/2014
• Initial Date FDA Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2014
• 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