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

Model Number	FG001-02
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The event occurred on (b)(6) 2022 at (b)(6).The complaint was received on october 6, 2022 by the saranas sales representative who was not present at the case.The facility reporting person indicated that prior to the procedure, the saranas early bird bleed monitoring system (8fr) was prepared at the scrub table per the instructions for use (ifu).The early bird battery isolation pull tab was removed to activate the device, and a green blinking light was observed on the device user interface display indicating that the device was functioning properly.The device was turned off and subsequently implanted into the patient as per the ifu.The early bird device was not to be activated for bleed monitoring until after the medical procedure was performed.The patient was undergoing a transcatheter aortic valve replacement (tavr) procedure.During the tavr procedure, internal bleeding events occurred.It was reported that a bleed had occurred due to a failed manta vascular closure device in the common left femoral artery.One of the doctors also reported that there may have been some bleeding from the epigastric artery.As such, the physicians performed a balloon tamponade of the left femoral artery and held pressure to help control the bleeding while the patient was in the catheterization lab.Afterwards, the physician's felt that they could send the patient to the floor.As such, the early bird device was activated, and the patient was transported to the cardiovascular intensive care unit.While in the cvicu, the patient developed a hematoma, became hypotensive and was transported back to the cath lab for surgical intervention.The bleeding was controlled, and the patient has since recovered.It was reported that the early bird did not trigger any bleed levels.However, the interventionalists felt that the device should've triggered a level 3 bleed.Section 6, warnings, in the saranas early bird instructions for use states that, "the early bird may not detect an internal bleeding complication if internal bleeding has already occurred prior to insertion of the introducer sheath or prior to initial bioimpedance measurement." section 13, functionality, in the ifu states that, "the early bird provides early detection of potential internal bleeding complications and monitors for internal bleeding progression based on baseline bioimpedance measurements and bioimpedance changes throughout the course of a procedure." because the patient had experienced significant bleeding in the left common femoral artery the tissue around the bleed detection array of the early bird device had become saturated.As such, once the early bird device was powered on the patient's bioimpedance baseline measurement (bleed rate threshold) was impacted such that the decrease in change of the bioimpedance value was not fast enough to trigger the early bird device algorithm.The early bird device was returned to the manufacturer for evaluation.The device was subjected to visual and electrical testing and no anomalies were observed.The device was also subjected to impedance stability testing and met test specifications.It is concluded that the early bird device did not malfunction.
Additional Manufacturer Narrative
According to the saranas engineering investigation, the exported early bird data log revealed that the fastest rate at which the patient's bioimpedance reduced was -2.0 milliohm/s, a rate lower than the early bird firmware v5.0.5.0 detection threshold of -2.5 milliohm/s.There was a delay in submitting this mdr due to difficulties with the esg gateway; refer to fda esg help desk tickets 338559 and 340672.

• 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: 16173395
• Report Number: 3016011241-2022-00001
• Device Sequence Number: 11345669
• Product Code: QFJ
• UDI-Device Identifier: 00866532000419
• UDI-Public: (01)00866532000419(17)240405(10)102610
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2024
• Device Model Number: FG001-02
• Device Lot Number: 102610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MANTA VASCULAR CLOSURE DEVICE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Race: White