Catalog Number EUP2515X |
Device Problems
Deflation Problem (1149); Material Deformation (2976)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/19/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
During a procedure a euphora rx ptca balloon catheter was intended to be used to treat a lesion.There was no damage noted to the packaging.The device was inspected with no issues noted.It was reported that difficulties were encountered removing the stylette and protective cover which resulted in a tear in the scrub personnel's glove and damage to the balloon.It was reported that the balloon was not functional after removal of stylette and protective cover.
|
|
Manufacturer Narrative
|
Product analysis summary: the sheath and stylette did not return for analysis.No deformation was evident to the distal tip.Contrast was visible in the balloon.The balloon was deflated, the balloon folds were expanded.There was no damage evident to the balloon.The proximal balloon bond was necked and stretched.It was not possible to perform inflation or deflation testing due to the condition of the proximal balloon bond.There was no other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Additional information: the device was used in the patient.The scrub replaced the glove before they continued on with the procedure.The balloon was inserted into the lesion and inflated as normal.However the balloon was slow to inflate.At this point it was known that the device was not functioning properly and negative pressure was performed.The balloon would not deflate.Eventually enough contrast/flush solution was removed to carefully remove the device from the lad lesion.No damage to the vessel was angiographically evident.The target lesion was then stented and post dilated with a good result.The patient was not harmed and is doing fine.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|