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

Model Number 777F8

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and three three-way stopcocks was returned for evaluation.An arrow contamination shield was located between 16 cm and 33.5 cm from the catheter tip.Tray, calibration cup, and arrow 9fr introducer kit were also returned with the catheter.The balloon was found to be torn around the balloon circumference at both the proximal and distal bonding sites.The torn balloon piece was not found inside the contamination shield, the introducer or the introducer kit tray.Resistance was felt when the catheter body passed the proximal adapter of the non-edwards contamination shield even though the adapter was at the unlock position.A lab sample catheter (model: 777f8) was also inserted into the non-edwards contamination shield and resistance was felt at the proximal adapter.The outer diameter of the catheter body was measured and found to be within specification at 0.111".All through lumens were patent without any leakage or occlusion.No visible damage or inconsistency to the catheter body or returned syringe was observed.Visual examination was performed under microscope at 20x magnification and with the unaided eye.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of balloon 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.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.It is common clinical practice to check balloon integrity by inflating it to the recommended volume in order to detect any asymmetry, or leakage condition before use of the catheter.It is unknown if user or procedural factors may have contributed to the event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that the balloon of the swan ganz catheter did not inflate when the catheter passed through an arrow contamination shield before use.The balloon inflated properly when it was tested before inserting into the contamination shield.The customer commented that there is a possibility that the issue was caused by the contamination shield malfunction, but requested evaluation.The device will be returned together with the arrow sheath introducer kit.The sheath introducer kit is planned to be evaluated by arrow after the device evaluation is completed by edwards.There were no patient complications reported.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500249
• MDR Report Key: 10931680
• MDR Text Key: 219524650
• Report Number: 2015691-2020-14792
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2020

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: 04/29/2022
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 63120684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2020
• 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