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 Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

The swan ganz catheter evaluation is in progress.A supplemental report will be sent with the investigation results.A device history record review was completed and documented that device met all specifications upon distribution.

Event Description

It was reported that resistance was felt when passing a guidewire through the swan ganz catheter during insertion on the first day of use.The guidewire and the catheter were removed from the patient.The customer tried again to pass the guidewire through the catheter outside the patient body, and an unknown material was found to come out from inside the device.The customer commented that it seemed that a coating agent derived from the guidewire.The guidewire and the catheter were exchanged and the problem was solved.The guidewire and unknown material were discarded by the hospital.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One catheter with attached monoject 0.8 cc limited volume syringe was returned for evaluation.The guidewire and unknown material were not returned for evaluation but were discarded by the hospital.No visible damage was observed from the catheter body, balloon, or returned syringe.A lab 0.025" guidewire (as recommended inch size in the ifu) was passed hub to tip and tip to hub without resistance.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.Balloon inflation test was performed using returned syringe with 0.8 cc air by holding the balloon under water for 5 minutes.Visual examination was performed under microscope at 20x magnification.Customer report of ¿resistance was felt when passing the guidewire through the catheter¿ could not be confirmed during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.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 standard practice to inspect the catheter before use.The ifu states to flush the catheter lumens and check balloon integrity including major asymmetry and leaks.It is unknown if procedural or user factors contributed to this event as the guidewire and foreign substance were not returned.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.

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: 9728021
• MDR Text Key: 192259982
• Report Number: 2015691-2020-10591
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2021
• Device Model Number: T173F6
• Device Catalogue Number: T173F6
• Device Lot Number: 62582043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Date Manufacturer Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2019
• 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