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Model Number M0063903200 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Block e1: initial reporter address (b)(6).Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.
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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 transurethral lithotripsy procedure performed on (b)(6) 2023.During the procedure, the sheath was damaged outside the patient.There were no more stone cone available; therefore, the procedure was aborted.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block e1: initial reporter address (b)(6).Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: a stone cone was received for analysis.A visual inspection observed the area of the cone with the white sheath and handle was completely separated from the rest of the body.The cone was received in an open state and a tangle was noted on the cone.The sheath around the cone was peeled.The reported event was confirmed.Based on the defects observed during analysis, it is most likely that the damage was caused by excessive force or manipulation.The tangled noted on the cone could prevent the cone from fully closing/opening.It is probable that force was exerted when they were testing the cone causing the wiring deformation and leading to the body break.Additionally, the instructions 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." therefore, the complaint investigation conclusion code selected is unintended use error, indicating that interaction between the user and the device caused or contributed to the error.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu) / labeling.
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Event Description
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It was reported that a stone cone nitinol retrieval coil was used in the ureter during a transurethral lithotripsy procedure performed on (b)(6) 2023.During the procedure, the sheath was damaged outside the patient.There were no more stone cone available; therefore, the procedure was aborted.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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