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

Model Number 777F8

Device Problems Break (1069); Material Rupture (1546); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

One catheter without any attached components was returned for evaluation.Balloon was found to be torn and missing at the central area of the balloon latex.Both balloon bonding sites were partially missing.No visible damage or inconsistency was observed from the catheter body.It was able to insert the catheter into a lab 9fr introflex introducer with contamination shield, which is the recommended size introducer per japan ifu.All through lumens were patent without any leakage or occlusion.Further evaluation was performed and the outer diameter of the catheter body was measured and found to be within specification at 0.110".Visual examination was performed under microscope at magnification 10x and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of catheter insertion issue could not be confirmed during the analysis; however, 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.This incident occurred before use so there was no patient compromise noted.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 swan ganz catheter got stuck in the contamination shield, and the balloon site was consequently damaged before use.The introducer used in this case was teleflex si-9903 arrow sheath introducer.There were no patient complications reported.

Manufacturer Narrative

Reference capa-20-00141.

• 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
• MDR Report Key: 8875719
• MDR Text Key: 154316950
• Report Number: 2015691-2019-02943
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/13/2019

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: 03/14/2021
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 61936732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/08/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1