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

Model Number 834F75

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

The swan-ganz involved in this case was received for evaluation.The reported event was confirmed.As received, blood was observed inside of the thermistor connector.A cut, slit, approximately 2mm, was observed at 18mm from the distal tip.A leakage was found from the cut/slit and thermistor connector when air was injected into proximal injectate lumen.At the same area, a cut, sliced off section, approximately 8mm, of catheter body was observed.The cut, sliced off section was not returned.No leakage was observed from other through lumens.The balloon inflated clear, concentric and remained inflated for more than 5 mins.Without leakage.No visible damage was found from balloon and returned syringe.An engineering investigation will be performed in order to consider any potential factors that may have contributed to this complaint.A supplemental report will be submitted accordingly upon investigation completion.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.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

As reported, during use in patient of this swan-ganz tri-lumen catheter, blood in the thermistor connector was noticed when the patient returned from a cardiothoracic surgery to the intensive care unit.As per further information provided, a high temperature value was displayed.However, the monitor alarmed and alerted the customer.Due to this temperature being so high and the suspected fault, co measurement was not set up, but pulmonary artery pressure (pap) was functional.There was no allegation of patient injury.The device was available for evaluation.

Event Description

As reported, during use in patient of this swan-ganz tri-lumen catheter, blood in the thermistor connector was noticed when the patient returned from a cardiothoracic surgery to the intensive care unit.As per further information provided, a high temperature value was displayed, however, the monitor alarmed and alerted the customer.Due to this temperature being high and the suspected fault, co measurement was not set up, but pulmonary artery pressure (pap) was functional.The patient was x-rayed to confirm the pac (pulmonary artery catheter) position.As per product evaluation results, it was found that a section of the catheter body had been cut/sliced off.There was no allegation of patient injury.

Manufacturer Narrative

Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.As part of the manufacturing process, the units go through a balloon inflation process.

• Brand Name: SWAN-GANZ CATHETERS
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18894223
• MDR Text Key: 337647525
• Report Number: 2015691-2024-01979
• 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: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 834F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: 73 YR
• Patient Sex: Female