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

Model Number	PXVP2284
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Additional 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 results become available.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.Model pxvp2284 additional product code is kra and additional 510(k) are k181684 and k896819.
Event or Problem Description
It was reported that a patient experienced a case with air embolism while being monitored with a vamp closed blood sampling system.Per follow up with customer, device was a pxvp2284 and lot may have been 65769851.Issue occurred during procedure after flushing a connected vamp (truwave (3cc)/vamp plus 84in (210cm) to an edwards pressure monitoring accessory tubing (k16912a) which was secured to the arrow radial artery catheterization set (14f24d0309) catheter.Flushing occurred when the system was connected post insertion.After flushing the arrow arterial line utilizing the toggle mechanism, the patient became unresponsive without gag reflex and required intubation.The team was able to diagnose the air embolism per mri.No troubleshooting steps were attempted.Patient remains in icu since (b)(6) 2024 with ongoing encephalopathy, r hemiparesis and respiratory failure on mechanical ventilation.Patient is a 66 y/o female, , 73.5 kg, pmh hypertension, hyperlipidemia, dm ii, hypothyroidism, primary hyperparathyroidism due to parathyroid adenoma s/p parathyroidectomy, and breast cancer dx 1994 with recurrence (2020) s/p chemotherapy, bilateral mastectomy, and anastrozole since (b)(6) 2021 and newly diagnosed aml (b)(6) 2024 s/p atra and hydroxyrea.
Additional Manufacturer Narrative
Additional information was received.On october 7,2024, per follow up with customer, the team was able to diagnose the air embolism per mri.Flushing occurred when the system was connected post-insertion.A follow up meeting was scheduled with the facility for 10/29/24 but was cancelled by (b)(6) regulatory.At that time, (b)(6) regulatory asked that any requests for additional information be in writing.A follow-up letter was sent to (b)(6) on 11/25/24 for additional information on the event and patient status.A response from regulatory at (b)(6) was received on 12/13/24 stating the following: after further detailed review of this event, we could not confirm that the patient experienced an air embolism.One pxvp2284, vamp plus was received by the evaluation laboratory.As received all connections were tight and secure.No visible damage was observed from the kit.Kit was primed and flushed without any problem.No leakage was observed from the kit during leak test.Water was drawn into vamp plus reservoir from the patient side of the kit and returned to patient side at the rate 1cc per second as instructed by the instructions for use (ifu) to test for any leakage across vamp system.No leakage was detected across vamp system during multiple cycles of aspiration and injection from the reservoir.Water was drawn from sample sites using returned syringe to check for leakage.No visible leakage across the sample sites during multiple sample draws.A device history record review was completed and documented that device met all specifications upon distribution.Per the ifu, air emboli is a known potential adverse event which has been identified as a possible complication associated with the use of a pressure monitoring kit with truwave disposable pressure transducer.Air emboli can enter the patient through stopcocks that are inadvertently left open, from accidental disconnection of the pressure setup, or from flushing residual air bubbles into the patient.The ifu cautions the user to remove all air bubbles to reduce the risk of air emboli and reduce loss of pressure signal.

• Brand Name: TRUWAVE, VAMP PLUS
• Common Device Name: 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 20408404
• Report Number: 2015691-2024-07670
• Device Sequence Number: 15058578
• Product Code: DXO
• UDI-Device Identifier: 07460691950177
• UDI-Public: (01)07460691950177(17)260510(11)240510(10)65769851
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142749
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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?: Yes
• Device Expiration Date: 05/10/2026
• Device Model Number: PXVP2284
• Device Lot Number: 65769851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 74 KG