MAUDE Adverse Event Report: SWAN-GANZ POLYMER BLEND TORQUE SUPPORT TRUE SIZE T-TIP TD CATHETER WITH AMC THRO; SWAN-GANZ CATHETER

Model Number T173F6

Device Problem Material Rupture (1546)

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

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

One catheter with detached monoject 3 ml syringe and monoject 0.8 cc limited volume syringe was returned for evaluation.Balloon was found to be ruptured and inverted to the distal side.After returning the balloon latex to the original position, the ruptured edges of balloon latex were not able to match up.All through lumens were patent without any leakage or occlusion.No visible damage was observed from the catheter body or balloon bonding sites.The returned monoject 3ml syringe was found to be missing the dimples that normally limits the maximum syringe volume at 0.8 ml.No other visual damage or abnormality was found on the returned syringes.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 "the balloon was ruptured since there was no dimpling site on the inflation syringe" 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 during use since there was no dimpling site on the inflation syringe.The catheter was exchanged and the problem was solved.There were no patient complications reported.Patient demographic information requested but unavailable.Additional information was obtained by the sales representative that two syringes were returned together with the catheter.One syringe has dimples and the other has no dimpling site.The reporter stated that the returned syringe with dimples was packaged with the new exchanged catheter.

Manufacturer Narrative

Additional information was received that the catheter was inserted through the femoral approach and the xemex 6fr introducer was used in this case.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ POLYMER BLEND TORQUE SUPPORT TRUE SIZE T-TIP TD CATHETER WITH AMC THRO
• Type of Device: SWAN-GANZ CATHETER
• MDR Report Key: 10063551
• MDR Text Key: 194658717
• Report Number: 2015691-2020-11880
• 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,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2021
• Device Model Number: T173F6
• Device Catalogue Number: T173F6
• Device Lot Number: 62661524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2020
• Date Manufacturer Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2019
• 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