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

Model Number 746HF8J

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2016

Event Type  malfunction  

Manufacturer Narrative

The product was discarded at the hospital; however, an image evaluation was performed based on photos taken by the customer.Two photos were received for evaluation.The photos confirmed a catheter body kink and a kink around the proximal injectate lumen port.The kinked area was the only part of the catheter captured in the photos.Blood was observed from the catheter body.An unknown introducer tip was observed on the catheter body at the proximal side of the kinked area.No other damage was observed from these photos.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of kink issue was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.

Event Description

It was reported that the catheter could not be advanced to the pulmonary artery after insertion during use.The customer attempted to remove the catheter once, but it could not pass through the introducer.A kink on the catheter was confirmed by radiography.Catheter was removed together with the introducer and another introducer was inserted into the patient.Device will not be returned due to infection.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2/VIP 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 ; 9497564386
• MDR Report Key: 5733343
• MDR Text Key: 47703491
• Report Number: 2015691-2016-01956
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K934742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2017
• Device Model Number: 746HF8J
• Device Lot Number: 60374335
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2016
• Date Device Manufactured: 03/24/2016
• 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