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	10/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Prytime is filing this report in an abundance of caution as the reboa catheter was present during a case that required a surgical cutdown for removal.This case involved a patient who presented to the facility after sustaining significant chest injuries from a motorcycle accident.The patient was hypotensive upon arrival and was given 2 units of prbcs and 2 units of ffp.Per the reporting surgeon, the patient continued to rapidly desaturate.Bilateral chest tubes were placed, and the patient was intubated.Once the patient was semi-stable, they conducted a ct scan where the imaging revealed left chest injuries with rib factures, questionable splenic lacerations (spleen was adjacent to a rib fracture), fractures in the pubic symphysis and pubic rami and a small amount of pelvic blood.The patient's blood pressure continued to drop so the surgeon decided to perform reboa.The initial sheath was exchanged to a 7fr sheath, and the catheter was inserted and placed in zone-3.The catheter was then stitched to the patient's skin and a dressing was applied.After the catheter balloon was inflated and partially occluded for 40-minutes, full deflation was ordered.Upon deflation, the surgeon noted blood in the balloon syringe.As he attempted to remove the device, the surgeon noted some resistance.He performed a cutdown and then consulted with vascular.The catheter and sheath were removed as a unit.It was noted that the opening in the artery was approximately 8/8.5 fr; which was surgically repaired by vascular.The investigation of the returned device identified a clean cut in the catheter shaft that extended into the balloon lumen.It was determined the removal issue was likely due to use error, in which a puncture was sustained to the outer shaft of the catheter during use.After sharing the device evaluation results with the surgeon, he reported that he may have nicked the catheter with a scalpel while removing the sutures holding the catheter in place.This prevented suction removal of fluid from the balloon, and it could not be removed through the sheath.At the time of this report, the patient remains in stable condition and is recovering with no known complications to the right lower extremity.Overall, there was no confirmed deficiency with the prytime product exhibited in this case.In addition, there is no 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 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; suite 300; boerne, TX 78006
• MDR Report Key: 18088909
• Report Number: 3026788751-2023-00019
• Device Sequence Number: 5847137
• 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): 11/07/2023

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: 10/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2023
• 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