MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN GANZ CATHETER; CATHETER, FLOW DIRECTED

Model Number 744F75

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2021

Event Type  malfunction  

Event Description

As reported, during a liver transplantation in a patient monitored with swan ganz catheter, the pulmonary artery pressure (pap) did not match patient condition and pap curve was abnormal, by chest x-ray a knot was seen in distal part of the catheter.It was not possible to remove the catheter on the same day due to patient clinical instability.The catheter was removed 4-7 days later through a femoral incision without any complications.The patient was later discharged.There was no allegation of patient injury.The device was not available for evaluation since it was discarded at hospital.

Manufacturer Narrative

It was further informed that the device was not available for evaluation since it was discarded at hospital.Without return of the product, edwards is unable to perform a complete investigation of the reported event.Nevertheless, five pictures were provided for review.Based on the image evaluation the customer report of catheter knot was confirmed.Two pictures showed the catheter body of what appeared to be a swan-ganz catheter cut next to the thermal filament.A knot could be seen at proximal end of the catheter next to the cut.Two other pictures showed an x-ray image where knot was visible.One picture showed a catheter inserted in a contamination shield.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.An engineering investigation has been initiated to consider any potential factors that may have contributed to this complaint.As per ifu "flexible catheters have been reported to form knots, most often as a result of looping in the right ventricle.Sometimes the knot can be resolved by insertion of a suitable guidewire and manipulation of the catheter under fluoroscopy.If the knot does not include any intracardiac structures, the knot may be gently tightened and the catheter withdrawn through the site of entry".Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions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

Based on further engineering investigation, catheter visual inspection process is performed as part of the manufacturing process.Looping or knotting is a known complication of swan ganz catheters.In the complication section of the ifu for this swan ganz catheter, the following statement is noted: flexible catheters have been reported to form knots, most often as a result of looping in the right ventricle.Sometimes the knot can be resolved by insertion of a suitable guidewire and manipulation of the catheter under fluoroscopy.If the knot does not include any intracardiac structures, the knot may be gently tightened and the catheter withdrawn through the site of entry.Per the instructions for use, there are two precautions noted regarding knotting of the catheter.Precaution: if a right ventricular pressure tracing is still observed after advancing the catheter several centimeters beyond the point where the initial right ventricular pressure tracing was observed, the catheter may be looping in the right ventricle which can result in kinking or knotting of the catheter.Deflate the balloon and withdraw the catheter into the right atrium.Reinflate the balloon and readvance the catheter to a pulmonary artery wedge position, then deflate the balloon.Precaution: catheter looping may occur when excessive length has been inserted, which could result in kinking or knotting.If the right ventricle is not entered after advancing the catheter 15 cm beyond entry into the right atrium, the catheter may be looping, or the tip may be engaged in a neck vein with only the proximal shaft advancing into the heart.Deflate the balloon and withdraw the catheter until the 20 cm mark is visible.Reinflate the balloon and advance the catheter.In this case there was no allegation or indication a product malfunction contributed to this event.The ifu has been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

• Brand Name: SWAN GANZ CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 13019626
• MDR Text Key: 282938431
• Report Number: 2015691-2021-06869
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/30/2022
• Device Model Number: 744F75
• Device Catalogue Number: 744F75
• Device Lot Number: 63076824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2020
• 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
• Patient Age: 51 YR
• Patient Sex: Male