MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH 1 FOOT CABLE; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PX601

Device Problem Fluid/Blood Leak (1250)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.Further evaluation regarding related quality issues is under investigation.The lot number was not provided thus a device history record was not 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 a part of the monthly review.

Event Description

It was reported there was csf leakage with an evd transducer.Patient had evd placed on (b)(6) 2023.The leakage was noticed when patient was having an emergent scan due to significant neuro decline.Edwards caps were replaced with hospital owned caps to resolve the issue.No additional troubleshooting was completed as the patient was going to emergent ct and no additional treatment needed for leakage.Nurse is unsure if neurosurgery replaced the entire system, but commented that it is protocol to replace evd system when sterility is broken.Per follow up with sales rep, he has visited site multiple times and each time rep cannot find anything in their practice that would cause leakage.Lot number is unknown and device is unable to be sent back.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH 1 FOOT CABLE
• 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
• MDR Report Key: 16326400
• MDR Text Key: 309150974
• Report Number: 2015691-2023-10683
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PX601
• Device Catalogue Number: PX601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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