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

Model Number T173F6

Device Problems Device Contamination with Chemical or Other Material (2944); Output Problem (3005)

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

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 0.8 cc limited volume syringe was returned for evaluation.The proximal injectate lumen was found to be completely occluded with an unknown clear material, located between 57 cm and 59 cm from the catheter tip.The distal lumen was also occluded with an unknown clear material from the catheter tip to the distal hub.The balloon inflated clear, concentric and remained inflated for 5 minutes without leakage.No visible damage to the balloon or returned syringe was observed.Both unknown materials were sent to chemistry for energy dispersive spectroscopy (eds) testing.Results from eds indicated the presence of the following elements from the material in the proximal injectate lumen: chloride, sodium, and aluminum results from eds indicated the presence of the following elements from the material in the distal lumen: iodine.Balloon inflation test was performed using returned syringe with 0.8 cc air by holding the balloon under water.Visual examinations were performed under microscope at 10x magnification and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.None of the substances that were found occluding the pa distal lumen and proximal injectate lumen are used within the manufacturing process.Therefore; the nonconformance cannot be confirmed as a manufacturing defect.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.The ifu states to flush catheter lumens with a sterile solution to ensure patency and to remove air.Also included in the ifu catheter preparation section is to connect the catheter¿s injectate and pressure monitoring lumens to the flush system and pressure transducers.Ensure that the lines and transducers are free of air.If the catheter does not flush appropriately before use the catheter should not be used and should be exchanged.It is unknown whether user or procedural factors contributed to the stated 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.No corrective or preventative actions are required at this time.

Event Description

It was reported that it was unable to withdraw blood from the proximal injectate lumen of the swan ganz catheter after insertion into the patient during use.Information such as what medication or drugs were used or if the catheter was tested or flushed prior to use is unknown.Patient demographic information requested but unavailable.There were no patient complications reported.

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 POLYMER BLEND TORQUE SUPPORT TRUE SIZE T-TIP TD CATHETER WITH AMC THRO
• MDR Report Key: 8567083
• MDR Text Key: 143947078
• Report Number: 2015691-2019-01536
• 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: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2020
• Device Model Number: T173F6
• Device Catalogue Number: T173F6
• Device Lot Number: 61719706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Date Manufacturer Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2018
• 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