MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD; CATHETER, OXIMETER, FIBEROPTIC

Model Number 774HF75

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

We received one 774hf75 catheter for examination.The balloon had a rupture in the central area around 100% of the circumference of the balloon.The balloon latex does not show any sign of latex deterioration.However, latex was missing at the ruptured site.All through lumens were patent without any leakage or occlusion.No visible damage was observed from the catheter body.Lot number was not provided, therefore review of the manufacturing records could not be completed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.

Event Description

It was reported that the balloon burst during testing.No patient complications were reported.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 5537915
• MDR Text Key: 41882645
• Report Number: 2015691-2016-01020
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 774HF75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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