BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X12CM; CATHETER, CONTINUOUS FLUSH
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Model Number 500-55112 |
Device Problems
Device Alarm System (1012); Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2022 |
Event Type
malfunction
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Event Description
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It was reported that there was removal difficulty.A 106x12cm ekosonic endovascular device was selected for the index procedure.The device was inserted and had air bubbles in the drug line that had to be aspirated, so the catheter was not able to be forward flushed.About 30 minutes into the therapy, while the patient was being transferred, an occlusion alarm sounded.At that point, the patient was returned to the table to pull out the infusion catheter to replace it with a new one.As the physician was removing the catheter, however, the catheter kept "catching" on something.There was a struggle to remove the catheter.The physician had to pinch the wire with a hemostat to hold it in place while pulling the infusion catheter back.The catheter was able to be removed and a new catheter passed over the wire smoothly.There were no further complications.The patient was doing well and ultimately received the correct dose of lytic.
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Event Description
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It was reported that there was removal difficulty.A 106x12cm ekosonic endovascular device was selected for the index procedure.The device was inserted and had air bubbles that had to be aspirated, so the catheter was not able to be forward flushed.About 30 minutes into the therapy, while the patient was being transferred, an occlusion alarm sounded.At that point, the patient was returned to the table to pull out the catheter to replace it with a new one.As the physician was removing the catheter, however, the catheter kept "catching" on something.There was a struggle to remove the catheter.The physician had to pinch the wire with a hemostat to hold it in place while pulling the infusion catheter back.The catheter was able to be removed and a new catheter passed over the wire smoothly.There were no further complications.The patient was doing well and ultimately received the correct dose of lytic.
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Manufacturer Narrative
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Device evaluated by manufacturer: the ic was returned with the cable cut; no usc was returned.No kinks or additional damage that would have contributed to the report of withdraw difficulty were observed.The device was able to be flushed without issue.The device was loaded into a bend jig with a guidewire inserted.The device was withdrawn with no difficulty or indication that the device was catching.The site complaint was not confirmed.
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Search Alerts/Recalls
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