MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT WITH 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 10/17/2023

Event Type  malfunction  

Manufacturer Narrative

The device is anticipated to be returned for evaluation but has not yet been received.A supplemental will be sent with the evaluation results.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

It was reported that an unknown black dust-like material was found in the pressure monitoring kit, before use.It is unknown exactly where the material was, but it was possibly inside the pressure tubing.The customer flushed the dust-like material out of the kit after finding it.The device and dust-like material will be returned for evaluation.There were no patient complications reported.

Manufacturer Narrative

One pressure monitoring set was received for product evaluation.The device history record review was completed and all inspections passed with no non-conformances.A supplemental mdr is being submitted due to product evaluation findings.One brown particulate was observed in the returned zipper bag.The brown particulate was approximately 2 mm x 0.5 mm in size.Event description stated that the customer flushed the particulate out of the kit after finding it.No other visible particulate was observed in returned kit.The returned kit was flushed continuously for 5 minutes, but no other particulates were flushed out from the kit.During product evaluation, the brown particulate returned by the customer with the kit was material consistent with that of pvc colorite.As per drawing of the different materials such as pressure tubing and connectors, the pvc material is part of all of these components, however, during the manufacturing process this type of brown particle cannot be generated.The process was reviewed and no evidence was found that the issue could be generated as part of the manufacturing floor.Additionally, the process has 100% of visual inspection that could detect this type of defect.Also, since it's unable to confirm in which component the brown particle was found, it could not be evaluated what is the affected component related to this event, therefore, no further actions will be taken with the supplier.

• Brand Name: PRESSURE MONITORING KIT WITH 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 ; one edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18080522
• MDR Text Key: 328046323
• Report Number: 2015691-2023-17294
• Device Sequence Number: 1
• Product Code: DXO
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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 Operator: Health Professional
• Device Expiration Date: 10/13/2022
• Device Model Number: PX260
• Device Lot Number: 64615615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 01/16/2024
• 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