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	Pseudoaneurysm (2605)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Prytime is filing this report in an abundance of caution due to the presence of an introducer sheath, which may have contributed to the development of a pseudoaneurysm.The introducer sheath is manufactured and labeled by the oem and included in prytime's convenience kit.This case involved an 83-year-old patient who was presented to the facility after being involved in a head on motor vehicle crash.The patient sustained fractures in all four extremities and was a transient responder to one unit of blood.In addition, the patient was a breast cancer survivor with bad lymphedema.Percutaneous access was gained at the left common femoral artery (cfa) and the reboa balloon catheter was placed.There were no issues encountered with the use of the catheter and sheath during the reboa procedure.A ct revealed the patient had a severe splenic laceration requiring the removal of the spleen.Once the surgical procedure was completed, the catheter was removed without issue and the sheath remained.The patient was transferred to icu and placed on a low dose of levophed and vasopressin with stable hemoglobin.The patient's lactate remained elevated.The following day, a pseudoaneurysm was noted at the sheath insertion site.Care was later withdrawn due to the severe nature of the patient's motor vehicle collision injuries in accordance with the family's wishes.Upon investigation of this incident, the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 pseudoaneurysm.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; boerne TX 78006
• Manufacturer Contact: brian young ; 12 upper balcones rd; boerne, TX 78006
• MDR Report Key: 18673152
• Report Number: 3026788751-2024-00003
• Device Sequence Number: 17990917
• Product Code: OFC
• UDI-Device Identifier: 00863092000101
• UDI-Public: 863092000101
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/08/2024

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: 01/10/2024
• Initial Report FDA Received Date: 02/08/2024
• 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: Other
• Patient Sex: Unknown