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Model Number M001235600 |
Device Problems
Positioning Failure (1158); Entrapment of Device (1212); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); Migration (4003); Material Split, Cut or Torn (4008)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 02/08/2023 |
Event Type
malfunction
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Event Description
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The interventional radiologist scheduled the patient for a procedure during which he intended to remove the patient's left nephroureteral catheter and replace it with a double-j stent.The physician had successfully removed the nephroureteral catheter over a guidewire and then placed an 11 french peel-away sheath.A 10 french by 26-cm double-j stent was then advanced over the guidewire.After deployment of the stent, it promptly migrated distally with the deformed proximal retention loop "kinking" in the ureter approximately 5-7 cm from the renal pelvis.The external retention "suture" was found to be unassociated/detached from the proximal aspect of the double j stent upon applying tension to it.Extensive attempts to reposition the stent using vascular snares and multiple catheter and guidewire combinations were attempted but were unsuccessful.The stent could not be appropriately engaged at its proximal aspect.Multiple attempts were made at passage of a guidewire into the stent, without success.Therefore, a guidewire was advanced into the urinary bladder and a vascular snare was used to engage the distal aspect of the double-j stent within the urinary bladder.A second 5 french catheter was advanced into the urinary bladder in an attempt to maintain access.The distal aspect of the stent was then withdrawn through the ureter into the renal pelvis.During attempts at removing the double-j stent completely, the snare severed the double-j stent approximately midway from the skin entry site and the entry site to the renal capsule.Limited attempts were made through the existing minimal incision to dissect down onto the stent remnant for removal.The could not be successfully achieved, so the procedure was modified and completed with the stent remnant remaining inside the patient.
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Event Description
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The interventional radiologist scheduled the patient for a procedure during which he intended to remove the patient's left nephroureteral catheter and replace it with a double-j stent.The physician had successfully removed the nephroureteral catheter over a guidewire and then placed an 11 french peel-away sheath.A 10 french by 26-cm double-j stent was then advanced over the guidewire.After deployment of the stent, it promptly migrated distally with the deformed proximal retention loop "kinking" in the ureter approximately 5-7 cm from the renal pelvis.The external retention "suture" was found to be unassociated/detached from the proximal aspect of the double j stent upon applying tension to it.Extensive attempts to reposition the stent using vascular snares and multiple catheter and guidewire combinations were attempted but were unsuccessful.The stent could not be appropriately engaged at its proximal aspect.Multiple attempts were made at passage of a guidewire into the stent, without success.Therefore, a guidewire was advanced into the urinary bladder and a vascular snare was used to engage the distal aspect of the double-j stent within the urinary bladder.A second 5 french catheter was advanced into the urinary bladder in an attempt to maintain access.The distal aspect of the stent was then withdrawn through the ureter into the renal pelvis.During attempts at removing the double-j stent completely, the snare severed the double-j stent approximately midway from the skin entry site and the entry site to the renal capsule.Limited attempts were made through the existing minimal incision to dissect down onto the stent remnant for removal.The could not be successfully achieved, so the procedure was modified and completed with the stent remnant remaining inside the patient.
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Search Alerts/Recalls
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