MAUDE Adverse Event Report: PRYTIME MEDIAL DEVICES, INC. REBOA CATHETER CONVENIENCE KIT; Catheter introducer kit

Catalog Number	KT1835C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Prytime is filing this report with an abundance of caution due to the presence of an introducer sheath, which may have contributed to the dissection of a patient's right iliac artery, requiring surgical intervention for repair.The introducer sheath is manufactured and labeled by the oem and included in prytime's convenience kit.The case involved a 17-year-old male patient who was presented to the facility after sustaining a gunshot wound at close range with an assault rifle.The patient's injuries were identified at the left buttocks and hip, possibility an exit wound in the left groin.Upon arrival, the patient was in hemorrhagic shock, tachycardic with a low blood pressure in the 60's.Blood products were administered in the ed and then the patient was transferred to the or.In the or, percutaneous access was gained at the right common femoral artery (cfa) via a 7fr sheath.Initial placement of the reboa catheter was inserted and inflated at zone-1 for approximately 10 minutes and then adjusted to zone-3 for 20 minutes; total occlusion time was approximately 30 minutes.Per the medical team at the user facility, it was unknown if partial or complete occlusion was utilized.No issues were reported during the use of the catheter or sheath.It was noted that the patient was small, with small vessels (-0.56cm femoral) and probably weighed less than 100lbs.Following completion of the or procedure, the catheter balloon was deflated and removed in or.The sheath remained in place, as ir was planning on using the sheath for additional procedures.The patient was transferred to ir where they discovered a dissection of the patient's right iliac artery.Ir physician placed a stent to repair the dissection.The exact cause of the iliac dissection was unknown; however, execution of the reboa procedure could not be ruled out as a potential contributing factor.Overall, there was no confirmed deficiency with the prytime product exhibited in this case.There was no reported or alleged failure of the kit components, the kit, or its labeling.

• Brand Name: REBOA CATHETER CONVENIENCE KIT
• Common Device Name: Catheter introducer kit
• Manufacturer (Section D): PRYTIME MEDIAL DEVICES, INC.; 12 upper balcones rd; suite 300; boerne TX 78006
• Manufacturer (Section G): PRYTIME MEDIAL DEVICES, INC.; 12 upper balcones rd; suite 300; boerne TX 78006
• Manufacturer Contact: brian young ; 12 upper balcones rd; suite 300; boerne, TX 78006
• MDR Report Key: 19510503
• Report Number: 3026788751-2024-00009
• Device Sequence Number: 3418590
• Product Code: OFC
• UDI-Device Identifier: 00863092000101
• UDI-Public: 863092000101
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: KT1835C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown