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Model Number M0063303070 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/03/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter address: (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 medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a gemini basket was to be used in the kidney on a stone retrieval procedure on (b)(6) 2022.According to the complainant, the gemini basket was unpacked and found the basket wire was broken.The procedure was cancelled and rescheduled on unknown date since there was no more basket available.There were no patient complications as a result of this event.
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Event Description
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It was reported to boston scientific corporation that a gemini basket was to be used in the kidney on a stone retrieval procedure on january 03, 2022.According to the complainant, the gemini basket was unpacked and found the basket wire was broken.The procedure was cancelled and rescheduled on unknown date since there was no more basket available.There were no patient complications as a result of this event.
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Manufacturer Narrative
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E1: initial reporter address: (b)(6).Block h6: device problem code a0401 captures the reported event of basket wire broken.Block h10: the returned mini gemini was analyzed, and a visual evaluation noted that the basket wire was in a good shape.However, the sheath was found torn and buckled/accordion adjacent to the head shrink.Additionally, the working length was kinked at the middle section.No other issues with the device were noted.The reported event was not confirmed.Based on all available information, it is possible that operational factors such as manipulation and excess of force could cause the working length to kink at the middle section.Once the working length is kinked, it is possible that interaction with the scope and the repeating actuation of the handle cause the tear and buckled/accordion of the sheath.Therefore, the most probable root cause of the failure observed during analysis is adverse event related to procedure.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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