MAUDE Adverse Event Report: EDWARDS LIFESCIENCES VAMP UNKNOWN; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	VAMPUNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	03/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned but the product evaluation has not been completed yet.A supplemental will be sent with the evaluation results, as well as the device history record review results when completed.Medwatch (b)(4) was received for this issue.
Event or Problem Description
It was reported that during use of this vesicle associated membrane protein (vamp) system (model pxvpl2284, lot 64598033), after drawing an arterial blood gas (abg) and flushing the device to clear the volume, the 31 year old male patient had a change in mental status.The patient became unresponsive, not responding to verbal or noxious stimuli, and not moving extremities.The acute stroke team was called and brain imaging was notable for pneumocephalus in right parieto-occipital region.The troubleshooting is unknown.The caregiver did not see any air bubbles in the line but it was reported that the patient suffered an air embolism and was unresponsive with right side deficit.
Additional Manufacturer Narrative
An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.A product risk assessment (pra) and a corrective and preventive action (capa) was opened to address the issues related to air bubbles causing air embolism in the patients seen at cleveland clinic.The root cause was determined to be use-error.The ifu instructions were evaluated and determined to be adequate for the safe and correct use of the product.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.
Additional Manufacturer Narrative
The model number previously reported, pxvpl2284 was changed to vampunknown as the returned device did not match the drawings for the devices sold to cleveland clinic.The following additional information for the patient was received from cleveland clinic: patient status - the ct of head was notable for punctate focus of pneumocephalus in the right parieto-occipital region.Bilateral cortical/subcortical diffusion restriction, possibly representing an acute to subacute process along the pres spectrum.He was treated for seizures, decreasing in frequency.Following up as an outpatient for seizures.Treatment administered - the patient was treated for seizures related to the air embolus with keppra.Procedure done in the or - patient had cabgx3 (lima-lad, rima-om1, svg-d1).Comorbidities - dm, hyperlipidemia, cad, iwmi s/p pci with stent to rca.Access site of the arterial line was the left brachial.
Additional Manufacturer Narrative
The product was returned for evaluation.The reported issue with the pressure monitoring kit was not able to be confirmed.As received, the pressure tubing of vamp plus system had been completely cut three inches distal from the proximal sample site.Blood was visible inside the sample sites, the pressure tubing, and the distal tubing connector.Both luer activated sample sites appeared intact.A leak test was not able to be performed on the vamp system due to the cut off tubing.There was no leakage detected from the iv set and attached dpt unit.The dpt sensor zeroed and sensed pressure accurately on hemosphere monitor.A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.An investigation into the model number is ongoing as the returned device does not match the drawings for the (b)(6).A supplemental will be sent with the results.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: VAMP UNKNOWN
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: jon diaz ; one edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 16637597
• Report Number: 2015691-2023-11944
• Device Sequence Number: 20178032
• Product Code: DXO
• UDI-Device Identifier: 00690103200348
• UDI-Public: (01)00690103200348(17)240906(11)220907(10)64598033
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/05/2023

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 Expiration Date: 09/06/2024
• Device Model Number: VAMPUNKNOWN
• Device Catalogue Number: PXVPL2284
• Device Lot Number: 64598033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 03/30/2023; 05/01/2023; 05/23/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 04/25/2023; 05/22/2023; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2022
• 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
• Outcome Attributed to Adverse Event: Disability; Hospitalization
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White