BOSTON SCIENTIFIC CORPORATION IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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Model Number 38270 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.
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Event Description
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It was reported that the tip broke off.A 5f c2 imager ii angiographic catheter was selected for a ureteric stent insertion procedure.An antegrade approach was used via the left nephrostomy tube.The imager ii catheter was placed into the entry sheath after being flushed with heparinized saline and lubricated with normal saline.When the catheter was in the left ureter, it was discovered that the distal tip was broken off but still attached to the catheter.The catheter was removed and discarded.Another of the same product and batch number was opened.During inspection of the catheter, which involved flushing and lubricating, the distal tip of the catheter detached in the radiologist's hand.A third catheter was then opened to check the tip.The tip was very fragile and easily removed from the catheter.No patient complications were reported, and the patient was stable post-procedure.The patient was admitted for routine observations post-procedure as pre-planned, and no escalation of care was required.
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Manufacturer Narrative
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A2: age at time of event - 18 years or older.
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Event Description
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It was reported that the tip broke off.A 5f c2 imager ii angiographic catheter was selected for a ureteric stent insertion procedure.An antegrade approach was used via the left nephrostomy tube.The imager ii catheter was placed into the entry sheath after being flushed with heparinized saline and lubricated with normal saline.When the catheter was in the left ureter, it was discovered that the distal tip was broken off but still attached to the catheter.The catheter was removed and discarded.Another of the same product and batch number was opened.During inspection of the catheter, which involved flushing and lubricating, the distal tip of the catheter detached in the radiologist's hand.A third catheter was then opened to check the tip.The tip was very fragile and easily removed from the catheter.No patient complications were reported, and the patient was stable post-procedure.The patient was admitted for routine observations post-procedure as pre-planned, and no escalation of care was required.It was further reported that the procedure was completed with a different device.
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