MAUDE Adverse Event Report: SARANAS, INC. EARLY BIRD BLEED MONITORING SYSTEM; INTRAVASCULAR BLEED MONITOR

Model Number	FG001-01
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)
Date of Event	06/16/2020
Type of Reportable Event	Death
Event or Problem Description
During the large-bore 16f sheath removal and wire exchange, the first early bird level 1 indication was triggered.Shortly thereafter, the patient's pressure dropped significantly, and it was determined at that time that the patients right common iliac was perforated.Dr.(b)(6) and staff began applying pressure while they assessed.Dr.(b)(6) then placed 3 atrium iliac covered stents to repair the right common iliac; this took roughly 8-10 minutes.An angiogram was performed to confirm the iliac stent placement and assess the situation.Under further examination, it was determined that there was another perforation near the aortic bifurcation.An aortic occlusion balloon (24 mm true balloon) was placed in the abdominal aorta to try and stop the bleeding.During this time, cpr and chest compressions were being performed.Roughly 18 minutes after the early bird indication, the patient had expired.The early bird was retrieved and shipped back to saranas for signal examination.Saranas chief medical officer then discussed the bleeding signal with dr.(b)(6).Patient information was not made available to saranas for this event.
Additional Manufacturer Narrative
Based on the investigation and data collected, it was determined that the ebbms did not cause or contribute to death, serious injury or illness for this event.The ebbms device functioned as intended as evidenced in the data showing the ebbms triggered after device activation indicating an internal bleed complication.Related report number: 3016011241-2022-00001.

• Brand Name: EARLY BIRD BLEED MONITORING SYSTEM
• Common Device Name: INTRAVASCULAR BLEED MONITOR
• Manufacturer (Section D): SARANAS, INC.; 2450 holcombe boulevard; suite x; houston TX 77021
• Manufacturer (Section G): SARANAS, INC.; 2450 holcombe boulevard; suite x; houston TX 77021
• Manufacturer Contact: odell roberts ; 2450 holcombe boulevard; suite x; houston, TX 77021 ; 2817014416
• MDR Report Key: 16441207
• Report Number: 3016011241-2023-00001
• Device Sequence Number: 16931589
• Product Code: QFJ
• UDI-Device Identifier: 00866532000402
• UDI-Public: (01)00866532000402(17)200731(10)503109G
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: DEN180021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2023

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: 07/31/2020
• Device Model Number: FG001-01
• Device Lot Number: 503109G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 24 MM TRUE BALLOON; LARGE-BORE 16F EDWARDS SHEATH
• Outcome Attributed to Adverse Event: Life Threatening; Congenital Anomaly; Required Intervention; Death
• Patient Sex: Unknown