MAUDE Adverse Event Report: PRYTIME MEDIAL DEVICES, INC. REBOA CATHETER CONVENIENCE KIT; Catheter introducer kit

Catalog Number	KT1835C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	05/02/2024
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 an introducer sheath, which may have contributed to the development of a thrombus formation requiring a thrombectomy for treatment.The introducer sheath is manufactured and labeled by the oem and included in prytime's convenience kit.The case involved a male patient who was presented to the facility after sustaining a fall injury a day or two prior.The patient was initially presented to another facility and then transferred to the current reporting facility.The patient was hypotensive upon arrival with an sbp in the 80's and into the 70's with two vasopressors infusing.Percutaneous access was gained at the left common femoral artery (cfa).The medical team expressed some difficulties gaining access and insertion due to the patient's large size but was ultimately successful.It was later noted that the patient's cfa was a very small caliber and was confirmed to have arterial calcification and arteriosclerosis.The reboa catheter was placed in zone-1 and the balloon was inflated for approximately 1.58 hours at partial occlusion.There were no issues encountered with the use of the catheter or the sheath during the reboa procedure.Following completion of the ir procedure, the catheter balloon was deflated and removed without issue.Approximately two hours later the sheath was removed; however, it is unknown how the sheath was managed while left in place.Shortly after sheath removal, the patient's lower left extremity pulses were absent; though the leg was not cold to the touch, no pulses were present.The vascular department conducted an angiogram which showed a significant thrombus of the left cfa and distal vessels.Vascular surgery conducted a thrombectomy for treatment of the thrombus.Post procedure, the patient's pulses returned.Upon investigation of this incident, the presence of the introducer sheath within the bloodstream could not be ruled out as a potential contributor to the development of the thrombus.Overall, there was no confirmed deficiency with the prytime product exhibited in this case.There was no reported or alleged failure of the kit components, the kit, or its labeling.

• Brand Name: REBOA CATHETER CONVENIENCE KIT
• Common Device Name: Catheter introducer kit
• Manufacturer (Section D): PRYTIME MEDIAL DEVICES, INC.; 12 upper balcones rd; suite 300; boerne TX 78006
• Manufacturer (Section G): PRYTIME MEDIAL 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: 19470359
• Report Number: 3026788751-2024-00008
• Device Sequence Number: 14344063
• Product Code: OFC
• UDI-Device Identifier: 00863092000101
• UDI-Public: 863092000101
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 06/05/2024

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: KT1835C
• 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: 05/09/2024
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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