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

Model Number 174F7

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

One catheter, model 174f7, with attached monoject 1.5 cc limited volume syringe and an attached non-edwards three-way stopcock at the proximal injectate hub was returned for evaluation.No visible damage or abnormality to the catheter body, balloon, or returned syringe was observed.All through lumens were patent without any leakage or occlusion.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.No error message was observed on vigilance ii monitor.The thermistor was submerged into a 36.9 c water bath and read 37.0 c on vigilance ii monitor.The thermistor circuit was continuous and there were no open or intermittent conditions.Balloon inflation test was performed returned syringe with 1.5 cc air by holding the balloon under water for 5 minutes.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 pressure measurement issue could not be confirmed during evaluation.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.With any hemodynamic monitoring, patient parameters can change quickly and dramatically.Patient parameters should correlate with the patient¿s clinical manifestations.In this case, it is unknown whether any user or procedural factors may have 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.

Event Description

It was reported that the indicated pulmonary arterial pressure (pap) / right ventricular pressure (rvp) were about 40 mmhg higher than expected during use.The event occurred when the right heart catheterization was performed after zeroing.The patient was not treated based on the incorrect value.An error message was not displayed.The value was not affected by the patient condition.Information such as indicated value, expected value, the shape of the waveform, if the value and waveform matched, if the trouble shooting was performed, whether there were any occlusion, leakage or kink noted in the catheter is unknown.The transducer used simultaneously was a non-edwards product.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 TD CATHETER
• Type of Device: SWAN-GANZ CATHETER
• MDR Report Key: 8538054
• MDR Text Key: 143437525
• Report Number: 2015691-2019-01412
• 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: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2020
• Device Model Number: 174F7
• Device Lot Number: 61478796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Date Manufacturer Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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