MAUDE Adverse Event Report: PRYTIME MEDICAL DEVICES, INC. ER-REBOA PLUS CATHETER; Catheter, intravascular occluding, temporary

Catalog Number	ER7232PLUS-EU
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Placenta praevia totalis percreta patient was originally planned for a c-section with elective use of the reboa through a special team experienced in endovascular procedures.Bleeding and worsening of the child's perfusion led to an unplanned, urgent c-section with blood loss greater than 2.5 liters.The consultant in charge decided to use the er-reboa plus catheter.The initial placement of the 7fr sheath was uneventful.The consultant had a formal training session for reboa, but in this case he didn't use a distal bp measurement nor did he use the recommended occlusion volume (2cc).He used 20cc for inflating the balloon.After occluding the aorta in zone iii, it led to good operation conditions for the obs.After finishing the operation, the team tried to deflate the balloon, which was followed with a profound hemodynamically instable situation.The reason was a ruptured retroperitoneal aorta (lesion 4cm ventrally, at the balloon position).Aorta was sutured and a patch was used.As of (b)(6) 2024, patient was at home and in good health.
Additional Manufacturer Narrative
User responsible person identified a lack of training as a factor in the incident.The individual in charge overinflated the balloon in a patient with small vasculature.20ml of fluid was used to inflate the balloon rather than the recommended 2ml in the ifu.Distal blood pressure measurements or imaging were not used to confirm occlusion.Ifu states "over-inflation of the balloon may result in damage to vessel wall and/or vessel rupture and/or balloon rupture and/or catheter damage".This was a zone 3 placement; therefore, the recommended inflation volume per the ifu is 2cc.The vascular surgeon that repaired the vessel stated that starting with 2cc would have been the appropriate starting inflation volume for this patient.The table below with inflation volumes is transcribed from the ifu: balloon diameter: inflation volume: 9mm , 2cc, 15mm , 5cc, 20mm , 8cc, 25mm , 13cc, 30mm, 20cc, 32mm (max).24cc (max).Additional training has been scheduled with the facility.

• Brand Name: ER-REBOA PLUS 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 ; 2103400116
• MDR Report Key: 20131170
• Report Number: 3026788751-2024-00011
• Device Sequence Number: 20654714
• Product Code: MJN
• UDI-Device Identifier: 00850001105057
• UDI-Public: 00850001105057
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K193440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2024

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: ER7232PLUS-EU
• 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: 07/30/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female
• Patient Weight: 61 KG