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

Catalog Number	PRP7226-PRO
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Prytime is filing this report with an abundance of caution due to the presence of the reboa catheter in the bloodstream, which may have contributed to thrombus formation requiring a thrombectomy and fasciotomy for treatment.The case involved a hypotensive patient who was presented to the facility with an unclear mechanism of injury; the patient was found near train tracks, indicating a possible pedestrian vs.Train moi.Early percutaneous access was gained at the right common femoral artery (cfa) using a 5fr sheath.A decision was then made to upsize the sheath and perform reboa (sheath was upsized to a 7fr).The reboa catheter was placed in zone-3 prior to performing a ct scan and partially occluded the vessel for approximately 1 hour.Following aortic occlusion, the catheter was deflated in the or and maintained in the aorta throughout the remainder of the pelvic surgical procedure and left in place until the end of a subsequent ir procedure at which point the catheter was removed.The total time the catheter and sheath remained in the vessel is unknown.There were no issues encountered during advancement of the catheter through the sheath, or during use of the catheter and sheath during the reboa procedure.The patient remained stable throughout the ct process and was then transferred to the or where the patient was prepared for pelvic repair surgery (including packing).Per the surgeon, the patient remained stable enough to deflate the catheter balloon and so it was fully deflated and remained in place.At the endpoint of the surgery, the patient was transferred to ir.Upon completion of the ir process the catheter was removed without issue, followed by the removal of the 7fr sheath.The following morning, post-procedure, it was discovered the patient's right leg was cold and had weak pulses.Vascular was consulted and a thrombectomy and fasciotomy were performed for the treatment of a thrombus located in the popliteal artery.Following the treatment, the patient's circulation was restored and showed no signs of deficit.Upon investigation of this incident and evaluation of the returned device, it was determined that the device functioned as intended.There is no alleged or observed device defect or deficiency.However, presence of the reboa catheter within the bloodstream could not be ruled out as a potential contributor to thrombus formation which required surgical intervention.

• 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; boerne TX 78006
• Manufacturer Contact: brian young ; 12 upper balcones rd; boerne, TX 78006
• MDR Report Key: 18493705
• Report Number: 3026788751-2024-00002
• Device Sequence Number: 6991483
• Product Code: MJN
• UDI-Device Identifier: 00850001105064
• UDI-Public: 850001105064
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 01/11/2024
• 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