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

Model Number PX260

Device Problem Contamination (1120)

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

Event Date 10/11/2023

Event Type  malfunction  

Event Description

As reported, before use in patient, when flushing this disposable pressure transducer, a black foreign material was found stuck inside the pressure tubing close to the dpt unit.There was no allegation of patient injury.The device was available for evaluation.Patient demographics unable to be obtained.

Manufacturer Narrative

The disposable pressure transducer involved in this case was received by our product evaluation laboratory for a full evaluation.One brown material was observed inside pressure tubing, on the inner tubing wall at approximately 63 cm proximal from pressure tubing female connector.The infrared spectrum of this material was consistent with that of polyvinyl chloride.The material stayed at the same location inside pressure tubing after 5 minutes of continuous flushing.The pressure tubing was cut, and a part of the material was found embedded within the inner tubing wall.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

Added information to section d4 (expiration date), h4 (device manufacturer date) and h6 (type of investigation).Updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Based on further engineering investigation it was identified that the condition is related to the supplier process.The material embedded within tubing wall was consistent with that of pvc and it was verified that it does not interact during edwards manufacturing process.The supplier has been notified in order to perform an investigation to avoid the recurrence of this issue.

• 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: 18054071
• MDR Text Key: 327134816
• Report Number: 2015691-2023-17193
• 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
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PX260
• Device Lot Number: 64526508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2022
• 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