MAUDE Adverse Event Report: PRYTIME MEDICAL 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Prytime is filing this report with 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 was presented to the facility after being involved in a motor vehicle collision; the patient had been pinned between two cars.During transport to the facility, the patient arrested; rosc was achieved in the trauma bay.The team placed the reboa catheter in zone 1 and was used successfully without issues.The patient was transferred to the or for liver repair as it was noted that the patient had a severe liver laceration.Once the patient was stable and hemorrhage control was achieved, the catheter was prepared for removal.Upon attempted removal, the trauma surgeon encountered difficulty in removing the catheter through the sheath.Vascular was consulted, where they recommended and performed a surgical cutdown to remove the device.In addition, vascular repaired the artery and ensured that perfusion was established to the affected limb.No complications at the insertion site were reported.Per the reporting surgeon, the patient is alive and recovering in icu.During investigation of this incident, it is not known whether all fluid was removed from the balloon prior to attempted removal.As noted in the ifu, failure to remove all fluid from the balloon prior to attempted removal may make it difficult or impossible to remove the catheter from the introducer sheath and/or vessel.Overall, there was no confirmed deficiency with the prytime product exhibited in this case.There was 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 MEDICAL 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: 19347206
• Report Number: 3026788751-2024-00006
• Device Sequence Number: 17812445
• Product Code: MJN
• UDI-Device Identifier: 00850001105064
• UDI-Public: 850001105064
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/17/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 05/17/2024
• 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