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	01/31/2024
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.The introducer sheath is manufactured and labeled by the oem and included in prytime's convenience kit.The case involved a 34-year-old female patient who was presented to the facility with heavy vaginal bleeding and demonstrated tachycardia and hypotension.The patient was found to have previa and placenta accreta spectrum.Estimated blood loss was 1 liter and mtp was started.Cesarean section was performed without incident.An additional 2 liters of blood loss was noted with ongoing blood loss from all surfaces.The uterus demonstrated dense adherence to the pelvic sidewalls, the bladder, and ureters.Once reboa procedure was determined, percutaneous access was gained at the right common femoral artery (cfa); micro-puncture was exchanged for 7fr sheath.Due to the patient's small habitus, there was difficulty during access, but eventually access was gained.It was noted that the patient was small, and the cfa was less than 4mm.The reboa catheter was placed and periodically cycled (inflate and deflate) for approximately 25-35 minutes (total occlusion time).Following completion of the procedure, both the sheath and catheter were removed without incident.Given the patient's small habitus, a femoral duplex was ordered and showed the right external iliac artery had thrombosed; a thrombectomy was performed.Following the treatment (two weeks, post-op), the patient was asymptomatic.Per the reporting surgeon, this issue was secondary to the presence of the sheath and does not imply that the sheath malfunctioned.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 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: 19218005
• Report Number: 3026788751-2024-00005
• Device Sequence Number: 12516858
• Product Code: OFC
• UDI-Device Identifier: 00863092000101
• UDI-Public: 863092000101
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/30/2024

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: 04/11/2024
• Initial Report FDA Received Date: 04/30/2024
• 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