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

Model Number	PX260
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One disposable pressure transducer (dpt) was received by our product evaluation laboratory.As received, no leakage was observed from the kit during leak test.However, three unknown black particles were found.Particle a was approximately 3x3 mm in size inside iv tubing at 80 cm from the housing, particle c was approximately 2x3 mm in size inside iv tubing at 38 cm from dpt housing and particle b was approximately 3x2 mm in size inside dpt housing.In addition, particles a, b and c did not dislodge during 5 minutes of continuous flushing.No particulates were found on filter paper.Finally, ir spectrum of unknown material showed similar absorption characteristics when comparing to silicone like material.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 or Problem Description
As reported, during set-up, this disposable pressure transducer snap-tab had saline leakage.The device was replaced by a new unit.There was no allegation of patient injury.Patient demographics were requested and unable to be obtained.The device was received for evaluation and three unknown black particles were found inside the iv tubing.There was no allegation of patient injury.
Additional Manufacturer Narrative
Updated section h6 (component code), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusion) added information to section h6 (type of investigation).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.Since the ir spectrum of the particles showed similar absorption characteristics when comparing to silicone-like material, an investigation was performed in the manufacturing lines to evaluate the possibility of this contamination being generated within the manufacturing process.Based on this, it is not confirmed that there is any machine or tool that could cause this nonconformance as silicone like material is not used on any part of the process.No potential cause for the condition reported was identified withing the manufacturing process.Nevertheless, a personnel acknowledgment was provided to the manufacturing personnel.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• Common Device Name: 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: 19631135
• Report Number: 2015691-2024-04948
• Device Sequence Number: 17915655
• Product Code: DXO
• UDI-Device Identifier: 07460691950191
• UDI-Public: (01)07460691950191(17)250112(11)230113(10)64591134
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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 Expiration Date: 01/12/2025
• Device Model Number: PX260
• Device Lot Number: 64591134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown