MAUDE Adverse Event Report: SWAN-GANZ POLYMER BLEND TORQUE SUPPORT TRUE SIZE TD CATHETER; SWAN-GANZ CATHETER

Model Number 174F7

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe at gate valve and non-edwards connector at the proximal injectate hub was returned for evaluation.Balloon was found to be ruptured at the central area of the balloon and the ruptured edges of balloon latex were not able to match up.Additionally, a tear, approximately 1mm in size, was found on the central side of the balloon latex.The edges of the balloon latex at the tear appeared to match up.All through lumens were patent without any leakage or occlusion.No visible damage to the catheter body, balloon bonding sites or returned syringe was observed.Visual examination was performed under microscope at 10x 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 rupture 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 ruptured prior to use.The patient demographic information is unknown.There were no patient complications reported.

Manufacturer Narrative

Correction to update g4 date to 21-dec-2020.

• Brand Name: SWAN-GANZ POLYMER BLEND TORQUE SUPPORT TRUE SIZE TD CATHETER
• Type of Device: SWAN-GANZ CATHETER
• MDR Report Key: 11158580
• MDR Text Key: 226595876
• Report Number: 2015691-2021-00135
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K915726
• 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: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2022
• Device Model Number: 174F7
• Device Lot Number: 63144411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2020
• 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