MAUDE Adverse Event Report: INARI MEDICAL, INC. INTRI24 INTRODUCER SHEATH; INTRODUCER CATHETER

Model Number	52-101
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Tachycardia (2095); Hypovolemia (2243); Low Oxygen Saturation (2477)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intri24 introducer sheath was returned to inari for evaluation and the findings will be summarized in a supplemental report.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.The t24 and t20 curve devices are not suspected as causing or contributing to the event.Blood loss and additional surgical intervention are listed in the device labeling as potential complications/adverse events.(b)(4).
Event or Problem Description
A (b)(6) female patient was diagnosed with a right atrial (ra) clot-in-transit (cit) adhered and massive bilateral pulmonary embolism (pe).The patient presented to the emergency department in critical condition and was placed on extracorporeal membrane oxygenation (ecmo) and a ventilator.On (b)(6) 2022, the patient was transferred to another hospital (remaining on ecmo and ventilator) for treatment.The initial surgical plan was to retrieve the ra clot and then wire the pulmonary arteries for pe thrombectomy; the patient was to remain on ecmo and the perfusionist was in attendance to clamp the circuit when necessary.On (b)(6) 2022 the patient underwent attempted thrombectomy with the inari intri24 introducer sheath, triever24 (t24), and triever20 (t20) curve.The intri24 sheath was used for access and the t24 and t20 curve were used for thrombectomy of the right atrium.To treat the atrial clot and to work with the emco cannula position in the inferior vena cava, several device exchanges were required, including the insertion of a 5 fr sheath into the intri24 sheath valve to gain wire position in the pulmonary arteries.The physician was successful in treating the right atrium and a total of 10 aspirations were performed.The estimated blood aspirated was 300 cc.Once the clot was cleared from the ra, the inari flowsaver was used to collect, filter, and return the patient's blood through the intri24 sheath.At this time, it was noted that the valve was not maintaining hemostasis.Upon examination, the valve of the intri24 sheath was compromised and blood was leaking from the hemostatic buttons and the primary port.Due to the pannus and drape positioning, the intri24 valve had been inadvertently obscured.During the 20-30 minutes that elapsed after the attempt to access the pulmonary arteries to address the pe, the patient became tachycardic with a heart rate (hr) in the 140 bpm range.This was likely attributed to the blood loss.As a result, a decision was made to postpone the pe thrombectomy.The patient was given a unit of blood, and second unit was given later that evening in the cardiothoracic intensive care unit due to low hemoglobin.The patient's pe was treated two days later (b)(6) 2022) with a successful result.Over the course of the next few days the patient was removed from ecmo, extubated, and discharged from the hospital.
Additional Manufacturer Narrative
The intri24 sheath was returned to the manufacturer and evaluated.The device was subjected to visual inspection, disassembly, and dimensional analysis.Initial visual inspection of the assembled device revealed a large hole in the hemostasis valve septum.Device disassembly confirmed two holes in the septum which included one small hole and one large hole that extended through the base of the septum.Dimensional analysis revealed all relevant measurements were within specifications.Final manufacturing inspection checks for integrity of hemostasis valve septum and all (100%) devices are inspected for this attribute.The root cause of the patient's blood loss and resulting tachycardia was the result of use error whereby the septum was punctured during use by improperly pressing the hemostasis valve when introducing the dilator.The device labeling includes the following precaution statement: failing to press hemostasis valve buttons while inserting or withdrawing a device through the intri24 introducer sheath may damage the valve.The device labeling also includes the following relevant instruction: depress buttons on the 24 fr sheath hemostasis valve, and advance selected interventional device over the guidewire and into the sheath.Manufacturer reference #: (b)(4).

• Brand Name: INTRI24 INTRODUCER SHEATH
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer (Section G): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer Contact: kit cariquitan ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 15465990
• Report Number: 3020347218-2022-00002
• Device Sequence Number: 7011592
• Product Code: DYB
• UDI-Device Identifier: 00850291007260
• UDI-Public: 00850291007260
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K212392
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2024
• Device Model Number: 52-101
• Device Catalogue Number: 52-101
• Device Lot Number: 22060001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/22/2022
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• 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: AMPLATZ SUPER STIFF GUIDEWIRE; FLOWSAVER; PIGTAIL CATHETER 5 FR; TRIEVER20 CURVE; TRIEVER24
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female