MAUDE Adverse Event Report: PRYTIME MEDICAL DEVICES, INC ER-REBOA; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number ER7232A

Device Problems Material Rupture (1546); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Foreign Body In Patient (2687)

Event Date 12/18/2017

Event Type  malfunction  

Event Description

A 7f prelude sheath introducer kit was used to access the pre-existing left femoral arterial line.A floppy-tipped guide wire was passed through the arterial line, and the line was withdrawn over the guide wire.The 7f sheath with dilator were then passed over the guide wire into the femoral artery, and the dilator and wire were removed.A 7f er-reboa catheter was used to measure the distance from the patient's xiphoid to the left femoral arterial catheter site (40 cm), as well as the distance from the patient's umbilicus to the arterial catheter site (25 cm).It was then introduced through the sheath and advanced to 25 cm.The arterial line setup was connected to the distal port, and a 10cc syringe filled with normal saline was connected to the balloon port.Normal saline was slowly injected into the balloon port until pressure and pulsations were felt, which was after the 10cc.During this time, the bp was observed to slowly improve and stabilized with the systolic blood pressure at approximately 100, at which time the valve was closed.The reboa catheter and introducer sheath were then secured to the patient's thigh with a silk suture and several strips of tape.The bp improved and stabilized, so then patient was taken from ed to ct.While in ct, the pt's bp then slowly decreased.I wore a lead apron and went into the scanner with the patient to interrogate the reboa balloon as the ct c/a/p was continued.I found that the reboa balloon was not holding pressure/volume.I withdrew the syringe and aspirated blood from the balloon port.The md noted that the balloon was not holding volume/staying inflated.The md notes the clinical picture was consistent with a ruptured reboa catheter balloon.The patient's bp persistently decreased, and the ct scan was aborted.The ct scan had shown the reboa catheter was noted with its tip in the aorta, with the balloon desufflated, but noted in the mid-infrarenal aorta.The pt.Was taken to surgery; shortly thereafter, the pt.Went into asystole.Cpr and internal cardiac massage was done, but he passed away.In the following days, the md thought about it and the md is unsure whether the reboa failed or not; she feels it was leaking, but was questioning whether its placement was correct.

Event Description

A 7f prelude sheath introducer kit was used to access the pre-existing left femoral arterial line.A floppy-tipped guide wire was passed through the arterial line, and the line was withdrawn over the guide wire.The 7f sheath with dilator were then passed over the guide wire into the femoral artery, and the dilator and wire were removed.A 7f er-reboa catheter was used to measure the distance from the patient's xiphoid to the left femoral arterial catheter site (40 cm), as well as the distance from the patient's umbilicus to the arterial catheter site (25 cm).It was then introduced through the sheath and advanced to 25 cm.The arterial line setup was connected to the distal port, and a 10cc syringe filled with normal saline was connected to the balloon port.Normal saline was slowly injected into the balloon port until pressure and pulsations were felt, which was after the 10cc.During this time, the bp was observed to slowly improve and stabilized with the systolic blood pressure at approximately 100, at which time the valve was closed.The reboa catheter and introducer sheath were then secured to the patient's thigh with a silk suture and several strips of tape.The bp improved and stabilized, so then patient was taken from ed to ct.While in ct, the pt.'s bp then slowly decreased.I wore a lead apron and went into the scanner with the patient to interrogate the reboa balloon as the ct c/a/p was continued.I found that the reboa balloon was not holding pressure/volume.I withdrew the syringe and aspirated blood from the balloon port.The md noted that the balloon was not holding volume/staying inflated.The md notes the clinical picture was consistent with a ruptured reboa catheter balloon.The patient's bp persistently decreased, and the ct scan was aborted.The ct scan had shown the reboa catheter was noted with its tip in the aorta, with the balloon desufflated, but noted in the mid-infrarenal aorta.The pt.Was taken to surgery; shortly thereafter, the pt.Went into asystole.Cpr and internal cardiac massage was done, but he passed away.In the following days, the md thought about it and the md is unsure whether the reboa failed or not; she feels it was leaking, but was questioning whether its placement was correct.

• Brand Name: ER-REBOA
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): PRYTIME MEDICAL DEVICES, INC; 13949 w colfax ave.; ste. 110; lakewood CO 80401
• MDR Report Key: 7193231
• MDR Text Key: 97308113
• Report Number: 7193231
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: ER7232A
• Device Catalogue Number: ER7232A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; NO OTHER THERAPIES; PT WAS INTUBATED AND RECEIVING IV FLUIDS.; PT WAS INTUBATED AND RECEIVING IV FLUIDS.; NO OTHER THERAPIES; PT WAS INTUBATED AND RECEIVING IV FLUIDS.
• Patient Age: 70 YR