|
Model Number 24672 |
Device Problem
Material Rupture (1546)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/05/2019 |
Event Type
malfunction
|
Event Description
|
It was reported that balloon burst occurred.A percutaneous transluminal angioplasty procedure was being performed.The 10% stenosed target lesion was located in the calcified and mildly tortuous superficial femoral artery.After deploying an eluvia stent, this 5.0 x 150, 135cm mustang balloon catheter was selected, when preparing for inflation angiography revealed contrast agent coming out from the device.When the device was removed from the patient, they found that the balloon had burst.The procedure was completed with another of the same device.No patient complications was reported.
|
|
Event Description
|
It was reported that balloon burst occurred.A percutaneous transluminal angioplasty procedure was being performed.The 10% stenosed target lesion was located in the calcified and mildly tortuous superficial femoral artery.After deploying an eluvia stent, this 5.0 x 150, 135cm mustang balloon catheter was selected, when preparing for inflation angiography revealed contrast agent coming out from the device.When the device was removed from the patient, they found that the balloon had burst.The procedure was completed with another of the same device.No patient complications was reported.
|
|
Manufacturer Narrative
|
Complaint device was returned for analysis.Blood was identified in the balloon which is indicative of a device leak.The returned device was loaded onto a mandrel and attached to an encore inflation unit.Positive pressure was applied, and a pinhole leak was identified mid balloon.No other issues were noted.A visual and microscopic examination of the balloon material identified no issues that could have contributed to the complaint incident.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.
|
|
Search Alerts/Recalls
|
|
|