MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number VO2346TTPL

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output below Specifications (3004)

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

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

One dpt was returned for examination.The reported event of pressure measurement issue was not confirmed.The dpt zeroed and sensed pressure accurately on a pressure monitor.The pressure did not show any drift during output drift testing and met specification.Electrical testing showed that the dpt electronic components were intact because both input and output impedance were within specifications.Zero-offset also met specification.No visible defect was found from the dpt cable connector.A supplemental report will be forthcoming with the device history results when received.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 patient¿s clinical manifestations.It is not known if user or procedural factors may have contributed to the stated event.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

It was reported that a value was lower than the expected value during use of this disposable pressure transducer (dpt).Which value had defect and the expected value are unknown.It was able to zero.The device was exchanged, and the problem was solved.The sample of tracing was not available.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

A review of the manufacturing records indicated that the product met specifications upon release.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: PRESSURE MONITORING KIT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• MDR Report Key: 9300413
• MDR Text Key: 195970782
• Report Number: 2015691-2019-04170
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2019

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: 11/15/2023
• Device Model Number: VO2346TTPL
• Device Lot Number: LJ0838MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 11/29/2019; 07/23/2020
• Supplement Dates FDA Received: 12/12/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1