BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X12CM; CATHETER, CONTINUOUS FLUSH
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Model Number 500-55112 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2022 |
Event Type
malfunction
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Event Description
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It was reported there was a labeling issue a 106x12cm ekosonic endovascular device (ekos) was selected for use in a pulmonary embolism (pe) procedure.When the physician tried to place the ultrasonic core wire in the patient, it was realized that something was wrong.The device was removed from the patient and was measured.The ultrasonic core wire measured 135cm.The device was exchanged and found the second box had the same issue.The device was then exchanged again, and treatment proceeded.
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Event Description
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It was reported there was a labeling issue.A 106x12cm ekosonic endovascular device (ekos) was selected for use in a pulmonary embolism (pe) procedure.When the physician tried to place the ultrasonic core wire in the patient, it was realized that something was wrong.The device was removed from the patient and was measured.The ultrasonic core wire measured 135cm.The device was exchanged and found the second box had the same issue.The device was then exchanged again, and treatment proceeded.
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Manufacturer Narrative
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Device analysis: the ekosonic ultrasonic core (usc) and ekosonic infusion catheter (ic) were returned to boston scientific for analysis.The device was visually inspected for damage and none was noted.The length of the ic measured 107.60 cm, meeting specification.The length of the usc measured 140.40 cm, which does not meet specification for a 106 cm usc.Instead this met specification for a 135cm usc, which confirmed the reported event.The usc was inserted in to the ic and the usc extended 24.30 cm past the distal tip of the ic.The catheter was connected to the control unit and the system information screen confirmed the reported sn as well as listed the device as a 106cm length with a 12 cm treatment zone.The catheter was placed in a water bath with a temperature of 37c and therapy was then started on the control unit.Approximately, two minutes into treatment, a 311 (no zones (groups) enabled) alert occurred.This alarm was dismissed and followed by an e006 (channel cross connection) alert.Therapy was stopped and the system was then shut down to conclude functional testing.
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