Model Number 500-56112 |
Device Problems
Material Integrity Problem (2978); Positioning Problem (3009)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/03/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that a guidewire perforated a catheter.An ekosonic infusion catheter was placed for treatment of pulmonary embolism.The catheter moved proximal to the treatment zone prior to inserting the ekosonic ultrasonic core.The infusion catheter was attempted to be re-wire with a non-boston scientific guidewire in order to reposition when the guidewire perforated the ekosonic catheter.The perforated catheter was removed and a new ekosonic catheter was used to complete the case.The patient is doing well.
|
|
Event Description
|
It was reported that a guidewire perforated a catheter.An ekosonic infusion catheter was placed for treatment of pulmonary embolism.The catheter moved proximal to the treatment zone prior to inserting the ekosonic ultrasonic core.The infusion catheter was attempted to be re-wire with a non-boston scientific guidewire in order to reposition when the guidewire perforated the ekosonic catheter.The perforated catheter was removed and a new ekosonic catheter was used to complete the case.The patient is doing well.
|
|
Manufacturer Narrative
|
H3: device evaluated by manufacturer: an infusion catheter (ic) and a ultrasonic core (usc) were returned to boston scientific for analysis.The infusion catheter is not the kitted ic to the returned usc.The device was inspected for any damage or irregularities.The ekos usc showed signs of use but no kinks or other damage were found.The infusion catheter showed signs of use.There were two obstructed coolant holes and a blood clot at the distal end.The ic was able to be flushed during decontamination and during analysis.The distal end clot opened enough during analysis to allow fluid to pass but the clot never fully dissipated.The ic was inspected with a microscope for a rupture but non was found.A guide wire was inserted and traversed the length of the catheter until it stopped at the clot at the distal marker band.Device analysis determined the condition of the returned device was not consistent with the reported information of damaged/defective.
|
|
Search Alerts/Recalls
|