MAUDE Adverse Event Report: PRYTIME MEDICAL DEVICES, INC. PREBOA-PRO CATHETER; Catheter, intravascular occluding, temporary

Catalog Number	PRP7226PRO
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A reboa catheter required a surgical cutdown for removal from the vessel.The case involved a patient who presented to the facility after sustaining multiple gun shot wounds from an ak-47.The patient sustained devastating injuries to the pelvis, iliac vein and artery, ivc, duodenum, pancreas, and colon.A reboa catheter was placed in the aorta and used successfully without issues for approximately 3-4 hours of mostly partial occlusion with a small amount of full occlusion.Once the trauma team repaired all of the injuries and stabilized patient, the catheter was prepared for removal.The physician encountered difficulty removing the catheter through the introducer sheath.Vascular performed a cutdown to remove the catheter and sheath.Vascular then repaired the artery.

• Brand Name: PREBOA-PRO CATHETER
• Common Device Name: Catheter, intravascular occluding, temporary
• Manufacturer (Section D): PRYTIME MEDICAL DEVICES, INC.; 12 upper balcones rd; suite 300; boerne TX 78006
• Manufacturer Contact: julie burgett ; 12 upper balcones rd.; suite 300; boerne, TX 78006 ; 2103400116
• MDR Report Key: 24133316
• Report Number: 3026788751-2026-00001
• Device Sequence Number: 18728066
• Product Code: MJN
• UDI-Device Identifier: 00850001105064
• UDI-Public: 850001105064
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2026

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: PRP7226PRO
• 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: 01/02/2026
• Initial Report FDA Received Date: 01/21/2026
• 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