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

Model Number PXVP2284AT3

Device Problem Contamination (1120)

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

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.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 a part of the monthly review.

Event Description

It was reported that the customer noticed a pxvp2284at3 with excessive silicone in the syringe.There was no allegation of patient injury.

Manufacturer Narrative

A supplemental mdr is being submitted due to change in reportability.The customer reported excessive silicone in the syringe.Per the drm, particulates not confirmed to be a metal, glass or mold as a result of the evaluation and with surface areas less than 0.8mm2 or a maximum particulate diameter less than 1.725mm does not pose a risk of injury to the patient.After clinician review of the description of the event, this is no longer considered reportable.

• Brand Name: PHOENIX 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 ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18937660
• MDR Text Key: 338201347
• Report Number: 2015691-2024-02120
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 07460691950436
• UDI-Public: (01)07460691950436(17)250518(11)230519(10)64980107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PXVP2284AT3
• Device Lot Number: 64980107
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2023
• 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