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

Catalog Number	PRP7226-PRO
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Prytime is filing this report with an abundance of caution as the reboa catheter was present during a case that required a surgical cutdown for removal.This case involved a male patient who presented to the facility after sustaining multiple gunshot wounds to the abdomen and pelvis.The patient was immediately sent to the or where significant bleeding from the liver was identified, requiring liver packing.While in the or, left cfa access was obtained via a 7fr sheath.After a hepatic artery embolization was conducted in ir, the patient was transferred to sicu where he began to show signs of profuse bleeding and mtp was initiated.The surgeon reported difficulty advancing the reboa catheter into the sheath and using significant force during insertion.The catheter was advanced to zone 1 for approximately one hour; the balloon was never inflated as the patient stabilized with blood products.The patient was returned to the or, where the balloon was inflated and partially occluded for approximately one hour.After the or procedures were completed, full deflation of the balloon was ordered.Upon deflation, the surgeon attempted to remove the device and realized the catheter had a stretched appearance associated with force exerted during attempted removal.The surgeon performed a surgical cutdown to allow for extraction of the sheath and catheter.A proximal and distal embolectomy was performed to remove a developing clot, and the arteriotomy was surgically repaired.The evaluation of the returned device identified severe stretching of the catheter shaft balloon bunching and damage to the introducer sheath causing it to have an accordion appearance.Ultimately, the patient expired due to metabolic derangements.The surgeon noted that the reboa procedure was beneficial overall.Upon investigation of this incident and the returned device evaluation, there was no confirmed deficiency with the prytime device or labeling.

• Brand Name: PREBOA-PRO CATHETER
• Common Device Name: Catheter, intravascular occluding, temporary
• Manufacturer (Section D): PRYTIME MEDIAL DEVICES, INC.; 12 upper balcones rd; suite 300; boerne TX 78006
• Manufacturer (Section G): PRYTIME MEDICAL DEVICES, INC.; 12 upper balcones rd; suite 300; boerne TX 78006
• Manufacturer Contact: brian young ; 12 upper balcones rd; boerne, TX 78006
• MDR Report Key: 18316967
• Report Number: 3026788751-2023-00020
• Device Sequence Number: 6278268
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2023

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 Catalogue Number: PRP7226-PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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