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Model Number M0063903200 |
Device Problems
Break (1069); Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter facility name (b)(6).This event was reported by the dealer.The physician present for this case was: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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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 to be used in the ureter during a ureteroscopic lithotripsy procedure performed on (b)(6) 2021.During preparation, the physician attempted to deploy the device but failed.Moreover, the sheath broke at the distal part of the stone cone.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition following procedure was reported to be stable.
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Manufacturer Narrative
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Block e1: initial reporter facility name is (b)(6).Initial reporter address 1 is (b)(6).Block e1: this event was reported by the dealer.The physician present for this case was: dr.(b)(6).Block h6: problem code a0401 captures the reportable event of sheath break.Block h10: the returned stone cone was analyzed, and a visual analysis found the coil was exposed.The proximal end of the blue sheath was torn/damaged.It appeared that the proximal end of the sheath had been forced over the proximal stop.The sheath was opened further than the limit such that the distal end of the sheath passed the end of the green coil coating.The defects prevented the device from being able to close properly during functional testing.The reported event was confirmed.Based on all available information, it is likely that while testing the device before use, excessive force on the outer sheath caused it to extend past the positive stop, contradicting the instruction to advance the sheath to the positive stop, and the coil was not able to open or close.Product investigation showed the sheathe was extended past the distal stop and the coil was unable to be opened.It is likely that while testing the device before use, excessive force on the outer sheath caused it to extend past the positive stop, contradicting the instruction to advance the sheath to the positive stop, and the coil was not able to open or close.The instructions for use (ifu) provides instructions for testing the device prior to use and states "prior to use, ensure that the coil is working properly by advancing the sheath over the coil to the positive stop and then retracting the sheath to open the coil.The sheath of the device should be straight during testing." therefore, the most probable root cause is failure to follow instructions a labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
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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 to be used in the ureter during a ureteroscopic lithotripsy procedure performed on (b)(6) 2021.During preparation, the physician attempted to deploy the device but failed.Moreover, the sheath broke at the distal part of the stone cone.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition following procedure was reported to be stable.
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Search Alerts/Recalls
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