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Model Number M0063903200 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Block h6: imdrf device code a040506 captures the reportable event of the tip was fractured.
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Event Description
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It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a ureteroscopic lithotripsy procedure performed on (b)(6) 2023.During the procedure, the coil could not be retracted, and the tip was fractured.The problem occurred outside the patient.Another stone cone was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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Block h6: imdrf device code a040506 captures the reportable event of the tip was fractured.Block h10: the returned stone cone was analyzed, and a visual inspection found the blue sheath was completely removed from the cone body.In addition, the green/blue sheath above the cone was detached as well.Functional testing could not be performed due to the separation of the blue sheath.The reported event was confirmed.Based on all available information, it is most likely that when the cone was tested, the separation of the blue and the blue/green sheath from the cone body was caused by excessive force or manipulation.The instruction for use (ifu) states "if resistance is encountered while attempting to withdraw the coil do not exert excessive force.To release the object from the device, advance the sheath to straighten the coil and remove the device." a labeling review was performed and there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).Based on all the available information, the investigation conclusion code is unintended use error, indicating that interaction between the user and the device caused or contributed to the error.
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Event Description
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It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a ureteroscopic lithotripsy procedure performed on (b)(6) 2023.During the procedure, the coil could not be retracted, and the tip was fractured.The problem occurred outside the patient.Another stone cone was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Search Alerts/Recalls
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