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 Problems Crack (1135); Leak/Splash (1354); Contamination /Decontamination Problem (2895)

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

Event Date 01/15/2016

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and 3 three-way stopcocks was returned for evaluation.A non-edwards contamination shield was located on the catheter body between 32 cm and 99 cm proximal from the catheter tip.No packaging or introducer was returned.As received, blood was observed from inside the contamination shield.The shield was removed for evaluation.Two 3 mm long punctures were found on the catheter body on the 90 cm marker.The punctures were located on the opposite side of each other.One puncture entered into the proximal infusion lumen and the other puncture entered into the thermal filament lumen.The distal and proximal injectate lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.No visible damage to the balloon or returned syringe was found.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examinations were performed under microscope at 20x magnification and with the unaided eyes.A device history record review was completed and documented that the device met all specifications upon distribution.Customer report of blood leakage 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 blood leakage was observed in the contamination shield after one hour of use.The clinician noted a crack on the catheter at the 90cm depth marker.The catheter was used in cardiac surgery.There were no patient complications reported by the customer.

• 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 ; 9497564386
• MDR Report Key: 5513902
• MDR Text Key: 41051668
• Report Number: 2015691-2016-00864
• 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: Physician
• Type of Report: Initial
• Report Date: 01/19/2016

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: 04/19/2017
• Device Model Number: 777HF8J
• Device Lot Number: 60201364R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2015
• 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