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	Vascular Dissection (3160)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown whether all fluid was completely 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.The size of the syringe used during the initial removal process was a 10cc syringe.Per the ifu, for balloon deflation and removal, "slowly deflate the balloon by opening the balloon stopcock and drawing a vacuum using the syringe (recommend using a 30cc syringe) until the balloon is completely deflated.".
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 initially presented to the facility after sustaining injuries from a motorcycle accident, in the morning.Later in the evening the patient developed abdominal compartment syndrome and was transferred to the or.Right femoral access was gained and a reboa catheter was placed in zone 1.There were no issues encountered during advancement of the catheter through the sheath, or during use of the catheter for the reboa procedure.After the surgery procedure was completed, the resident surgeon attempted removal of the catheter through the sheath and met resistance.The main surgeon noted that a 10cc syringe was used and changed to a 30cc syringe and attempted the removal procedure without success.Vascular surgery was consulted where they performed a cutdown to remove the catheter and sheath as one unit.Upon investigation of this incident, it was determined that the likely cause of removal difficulty may be attributed to use-error, as it is not known whether all fluid was removed from the balloon prior to attempted removal and that the recommended 30cc syringe (per the ifu) was not utilized during the initial removal attempt.Overall, there was no confirmed deficiency with the prytime product exhibited in this case, nor a reported or alleged failure or deficiency of the prytime catheter or its labeling.

• 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: 18077628
• Report Number: 3026788751-2023-00018
• Device Sequence Number: 18074770
• Product Code: MJN
• UDI-Device Identifier: 00850001105064
• UDI-Public: 850001105064
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/06/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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