MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC TRUWAVE, VAMP PLUS; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	PXVPL2284
Health Effect - Clinical Codes	Pneumocephalus (4587); Altered State of Consciousness (4589)
Date of Event	03/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During use of vesicle associated membrane protein (vamp) system, an arterial blood gas was drawn.After flushing the device to clear the volume the patient had a change in mental status.Patient became unresponsive, not responding to verbal or noxious stimuli, and not moving extremities.Acute stroke team was called.Brain imaging notable for pneumocephalus in right parieto-occipital region.Manufacturer response for transducer, pressure, catheter tip, truwave, vamp plus (per site reporter).Manufacturer is completing internal testing to test system.

• Brand Name: TRUWAVE, VAMP PLUS
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 16609724
• Report Number: 16609724
• Device Sequence Number: 11975610
• Product Code: DXO
• UDI-Device Identifier: 00690103200348
• UDI-Public: (01)00690103200348
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/17/2023
• Report Date (Section F): 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PXVPL2284
• Device Catalogue Number: PXVPL2284
• Device Lot Number: 64598033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Hospitalization
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: White
• Date Report Sent to FDA: 03/17/2023