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

Model Number PX260

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 12/20/2022

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.

Event Description

As reported, during set up with this pressure monitoring set, a foreign material was found inside the pressure tubing.Patient demographics were requested and unable to be obtained.There was no allegation of patient injury.Follow-up has started for device return.

Manufacturer Narrative

One pressure monitoring set was received at our product evaluation laboratory for a full evaluation.The report of foreign material was confirmed.An unknown dark brown particulate, approximately 21 cm proximal from pressure line distal male connector was observed inside pressure tubing.The particulate was approximately 0.4x 0.1cm in size, attached to the inner wall of pressure tubing.The particulate stayed at the same location on pressure tubing after 5 minutes of continuous flushing.As per further chemistry analysis, ir spectrum of unknown material showed similar absorption characteristics when comparing to poly(vinyl chloride) like material.The lot number for this device was not supplied.Therefore, the related manufacturing records for this device were unable to be reviewed.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.

Manufacturer Narrative

Further investigation was completed by the engineers in the manufacturing site and it was determined that this issue was potentially related to the supplier process; therefore, the supplier has been notified in order to perform an investigation to avoid the recurrence of this issue.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: 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: 16094180
• MDR Text Key: 308563375
• Report Number: 2015691-2023-09946
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2023

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 Model Number: PX260
• Device Catalogue Number: PX260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 01/27/2023; 03/14/2023
• Supplement Dates FDA Received: 02/17/2023; 03/16/2023
• 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