MAUDE Adverse Event Report: PRYTIME MEDICAL 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	Unspecified Tissue Injury (4559)
Date of Event	12/14/2023
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 surgical intervention for removal.This case involved a patient who was presented to the facility after sustaining injuries from a high-speed motorcycle accident.Upon arrival, the patient's blood pressure was in the 80-90's with hr in the 140's.The patient was intubated, and a negative fast exam was obtained.Right femoral access was gained and a reboa catheter was placed in zone 1.Partial occlusion was performed for a cumulative time of 25 minutes and full occlusion was performed for 25 minutes.A total of three inflation/deflation cycles were required, as the patient became hypotensive during deflation.Upon completion of the surgical procedure, the surgeon attempted to remove the catheter through the sheath and met resistance.Vascular surgery was consulted and performed a surgical cutdown to remove the catheter and sheath as a unit.No complications at the insertion site were reported.During investigation of this incident, it is not known whether all fluid was removed from the balloon prior to attempted removal.As noted in the ifu, failure to remove all fluid from the balloon prior to attempted removal may make it difficult or impossible to remove the catheter from the introducer sheath and/or vessel.There was no reported or alleged failure or deficiency of the prytime catheter or its labeling.The surgeon stated that he was fortunate to have the reboa for this patient and commented that "being able to occlude the aorta without having to open the chest, is what i think allowed us to get rosc.".

• 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 (Section G): PRYTIME MEDICAL 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: 18495232
• Report Number: 3026788751-2024-00001
• Device Sequence Number: 17906570
• 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): 01/11/2024

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: PRP7226-PRO
• 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: 12/18/2023
• Initial Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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