MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUWAVE DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PX260

Device Problems No Device Output (1435); Detachment of Device or Device Component (2907)

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

Event Date 02/08/2023

Event Type  malfunction  

Manufacturer Narrative

The disposable pressure transducer involved in this case was received by our product evaluation laboratory for a full evaluation.The report of pressure values could not be obtained was not able to be confirmed.As received, dpt zeroed and sensed pressure accurately on pressure monitor.Electrical testing showed that both input impedance and output impedance were within specifications.Zero-offset also met specification.However, distal pressure tubing male connector was found missing.Distal end of the pressure tubing appeared straight and even and no visible residues of bonding material were visible.It appeared that distal tubing male connector had not been bonded.The tubing was measured to be 11" in length being within specifications.Tubing od, 0.139" near the distal tip, was within specification 0.140"+/-.002".Engineering evaluation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation result.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 with this disposable pressure transducer, pressure values could not be obtained.There was no allegation of patient injury.The device was available for evaluation.Patient demographics were requested and unable to be obtained.

Manufacturer Narrative

Updated: h6 (component code, investigation findings, investigation conclusions).Added: h6 (type of investigation) h10 manufacturer narrative: after the complaint investigation assessment done, it could be concluded that the most probable cause for the issue of missing pressure tubing connector was attributed to manufacturing.Manufacturing operators were properly trained on all the procedures that rule the dpt assembly process.Nevertheless, the manufacturing personnel has been notified about this condition.

Manufacturer Narrative

The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met and inspections passed successfully.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17285853
• MDR Text Key: 318656884
• Report Number: 2015691-2023-14467
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222216
• 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,Followup
• Report Date: 08/14/2023

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: 05/12/2024
• Device Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 64344639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 07/14/2023; 08/13/2023
• Supplement Dates FDA Received: 08/10/2023; 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2022
• 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