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	Vascular Dissection (3160)
Date of Event	09/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two factors may have played a role in the technical difficulties summarized above.One, it is unknown whether all fluid was completely 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.The second is the size of the syringe used during the removal process was a 10ml syringe.Again, per the ifu, for balloon deflation and removal, "slowly deflate the balloon by opening the balloon stopcock and drawing a vacuum using the syringe (recommend using a 30cc syringe) until the balloon is completely deflated.".
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 surgical intervention for removal.The case involved a patient who was presented at the facility with a gunshot wound.A sheath was placed in the right cfa in preparation for a reboa procedure.The balloon catheter was inserted into zone one and inflated with partial occlusion for three-hours.Per the surgeon, they conducted two cycles (cyclic inflation/deflation) as the procedure was lengthy and required extended balloon inflation.There were no issues encountered during advancement of the catheter through the sheath, or during use of the catheter for the reboa procedure.After the operating procedure was completed, the balloon catheter was deflated and prepared for removal.The trauma surgeon reported difficulty during attempted removal of the catheter through the sheath and consulted with the vascular department.Vascular performed all required steps for the removal process and still met resistance.To remove the catheter, the vascular surgeon proceeded with a vertical incision and removed the catheter and sheath as one unit.He noted that since he did not pull the catheter through the tissue, there were no complications.He performed an arteriotomy and stated the patient was healing fine.Upon investigation of this incident, it is not known whether all fluid was removed from the balloon prior to attempted removal.Also, it was noted by the first surgeon that during the deflation procedure a 10cc syringe was used, whereas a 30cc syringe was used as per the vascular surgeon.Overall, there was no confirmed deficiency with the prytime product exhibited in this case.It was determined that the likely cause of removal difficulty may be attributed to use-error, as a 30cc is recommended in the ifu.

• 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 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: 18062283
• Report Number: 3026788751-2023-00017
• Device Sequence Number: 12637481
• Product Code: MJN
• UDI-Device Identifier: 00850001105064
• UDI-Public: 850001105064
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2023

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: Not provided
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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