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

Model Number 096F6J

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Event Description

It was reported that during a procedure, while using this swan-ganz catheter, the pressure value was unstable.The value fluctuated between zero and couple of dozen mmhg.The expected value was around 10 mmhg.The patient was not treated based on the incorrect value.The catheter was replaced, and the problem was solved.There was no other trouble shooting performed.The customer did not acknowledge any occlusion, leakage, or kink.The data logs were not provided.Information such as which pressure value was inaccurate, or if an abnormal waveform was observed is unavailable.It is unknown if the value and the waveform matched, if an error message was observed, or if the value was affected by the patients condition.The patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One model 096f6 catheter with monoject 1 cc limited volume syringe was returned for examination.The reported event of the pressure issue was not able to be confirmed during evaluation.All through lumens were patent without any leakage or occlusion.There was no visible damage or inconsistency observed from the catheter body, the balloon or returned syringe.The balloon inflated clear, concentric, and remained inflated for more than five minutes without leakage.The catheter passed the pressure test with lab dpt.Per edwards ifu, "poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively complaint pressure tubing, small bore tubing, loose connections, or leaks".A review of the manufacturing records indicated that the product met specifications upon release.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.It is not known if some procedural factors may have contributed to the event.Although no fault was found, an investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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.

• Brand Name: SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 12848028
• MDR Text Key: 285742609
• Report Number: 2015691-2021-06389
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2023
• Device Model Number: 096F6J
• Device Lot Number: 63874072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2021
• 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