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

Model Number 774HF75J

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe was returned for evaluation.A non-edwards contamination shield was located on the catheter body between 18 cm and 54 cm proximal from the catheter tip.No packaging or introducer was returned.Clear solution was observed in the attached syringe as received in the decontamination lab.The balloon inflated but failed to maintain its inflation due to an interlumen leak in the catheter body between the balloon inflation lumen and the distal lumen.The attached non-edwards contamination shield was removed for evaluation.The interlumen leak in the catheter body was confirmed to be under the thermal filament between 13 cm and 24.5 cm proximal from the catheter tip, however, the exact location of the interlumen leak was not able to be confirmed.The proximal injectate lumen was patent without any leakage or occlusion.No visible damage to the catheter body, balloon, or returned syringe was observed.Balloon inflation testing was performed using returned syringe with 1.5 cc air.Visual examination was performed under microscope at magnification 20x and with the unaided eyes.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.The customer report 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 saline was aspirated into the inflation syringe when the balloon was deflated on the first day of use.Additionally, the balloon deflated with the inflation syringe attached to the gate valve.There were no patient complications reported.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/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 ; 9497564386
• MDR Report Key: 6003593
• MDR Text Key: 56590105
• Report Number: 2015691-2016-02941
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 774HF75J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Date Manufacturer Received: 09/13/2016
• 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