MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. MEDRAD ADVANTA SINGLE PATIENT DISPOSABLE SET; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Lot Number	214003
Health Effect - Clinical Codes	Air Embolism (1697); Low Blood Pressure/ Hypotension (1914); Diaphoresis (2452); Diminished Pulse Pressure (2606)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Air bubbles seen in tubing during cardiac cath procedure.Patient became symptomatic, diaphoretic, hypotensive, st elevation noted without pulses pea (pulseless electrical activity).Cpr initiated, code blue activated.Rosc (return of spontaneous circulation) achieved after 2 rounds of cpr.Patient to icu awake, alert, and stable condition.Fda safety report id# (b)(4).

• Brand Name: MEDRAD ADVANTA SINGLE PATIENT DISPOSABLE SET
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; indianola PA 15051 0780
• MDR Report Key: 14885374
• Report Number: MW5110636
• Device Sequence Number: 6289540
• Product Code: DXT
• UDI-Device Identifier: 00616258021485
• UDI-Public: 0100616258021485
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/29/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2023
• Device Lot Number: 214003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 98 KG