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Model Number M0063901050 |
Device Problems
Break (1069); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(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 zero tip basket stone retrieval basket was to be used in the kidney during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2019.According to the complainant, when the zero tip basket was inspected prior to the procedure, after opening and closing the basket once as a test, the sheath was found buckled and broken at the distal end.As a result, the basket failed to closed.Another zero tip basket was used to complete the procedure.No patient complications were reported as a result of this event.The patient's condition at the conclusion of the procedure is reported to be good.
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Manufacturer Narrative
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Device code 1069 captures the reportable event of sheath break at the distal end.Visual analysis of the returned device found the basket was opened when received.The sheath was found buckled and detached in the proximal section, and bent at the distal end.Additionally, the sheath was found retracted in the distal section due to the buckled sheath at the proximal section.The handle was actuated; however, the basket was unable to close completely.Based on all available information, the failures found are issues that could have been generated due to the manipulation of the device during unpacking/prepping/testing.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
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Event Description
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It was reported to boston scientific corporation that a zero tip basket stone retrieval basket was to be used in the kidney during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2019.According to the complainant, when the zero tip basket was inspected prior to the procedure, after opening and closing the basket once as a test, the sheath was found buckled and broken at the distal end.As a result, the basket failed to closed.Another zero tip basket was used to complete the procedure.No patient complications were reported as a result of this event.The patient's condition at the conclusion of the procedure is reported to be good.
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Search Alerts/Recalls
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