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 03/14/2022 |
Event Type
malfunction
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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 ureteroscopy lithotripsy procedure performed on (b)(6) 2022.During preparation, when the device was unpacked, the distal end of the sheath broke when retracting the tip.The procedure was completed with another stone cone nitinol retrieval coil.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
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Manufacturer Narrative
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Device code: (b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch 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 used in the ureter during a ureteroscopy lithotripsy procedure performed on (b)(6) 2022.During preparation, when the device was unpacked, the distal end of the sheath broke when retracting the tip.The procedure was completed with another stone cone nitinol retrieval coil.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
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Manufacturer Narrative
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Block h6: device code a0401 captures the reportable event of sheath break at the distal end.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation noted that the blue sheath was torn towards the proximal end allowing the core wire to show.No other notable defects noted.The reported event was confirmed.Based on all available information, it is most likely that the damage was caused during the testing of device with the use of excessive force or manipulation.Therefore, the most probable root cause is unintended use error.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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Search Alerts/Recalls
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