MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET (W/TRUWAVE DISPOSABLE PRESSURE TRANSDUCER & VAMP); CATHETER, CONTINUOUS FLUSH

Model Number PXVP2284DZ

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

One single dpt - vamp plus kit with saline bag was returned for examination.The reported event of inaccurate readings was not confirmed.The dpt zeroed and sensed pressure accurately on the laboratory pressure monitor.Pressure did not show any drift during output drift testing and met specifications.Electrical testing showed that both input impedance and output impedance were within specifications and the zero-offset also met specification.No leakage or occlusion was detected from the kit during pressure test.A device history record review was completed and documented that the device met all specifications upon distribution.As per ifu, poor dynamic response can be caused by air bubbles, clotting, and excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.The assembly may be tested for dynamic response by observing the pressure waveform on an oscilloscope or monitor.Bedside determination of the dynamic response of the catheter, monitor, kit and transducer system is done after the system is flushed, attached to the patient, zeroed and calibrated.A square-wave test may be performed by pulling the snap tab device and releasing quickly.Pressure readings can change quickly and dramatically because of loss of proper calibration, loose connection, or air in the system.Pressure readings should correlate with the patients clinical manifestations.In this event, there was no patient compromise noted.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 a disposable pressure transducer as part of a control study, the blood pressure values were 169/64 mmhg, mean 89, while that of the cardiologist was 129/63 mmhg, mean 93.After a coronary angiography examination, the blood pressure measured by the cardiologist was 159/57 mmhg, mean 89 and that measured by edwards dpt was 190/70 mmhg, mean 102.The cardiologist used philips hemo system with an acist cvi angio touch kit.There was no error message displayed.The patient was given glyceryl nitrate from cardiologist during examination.There was no allegation of patient injury.

Manufacturer Narrative

Additional information was received that the patient did not receive treatment due to the inaccurate dpt values.The glyceryl nitrate was given to dilate and and examine the coronary artery.Additionally, manufacturing and expiration dates were added according to the device history record review.

• Brand Name: PRESSURE MONITORING SET (W/TRUWAVE DISPOSABLE PRESSURE TRANSDUCER & VAMP)
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 12433364
• MDR Text Key: 272724676
• Report Number: 2015691-2021-05041
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2022
• Device Model Number: PXVP2284DZ
• Device Catalogue Number: PXVP2284DZ
• Device Lot Number: 63479806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 11/02/2021
• Supplement Dates FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PHILIPS HEMO SYSTEM, ACIST CVI ANGIO TOUCH KIT
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 54 KG