BOSTON SCIENTIFIC CORPORATION SEGURA HEMISPHERE; DISLODGER, STONE, BASKET, URETERAL, METAL
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Model Number M0063801070 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/18/2020 |
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 segura hemisphere basket was used in the ureter during a cystoscopy left ureteroscopy stone manipulation laser lithotripsy bladder biopsy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the physician noticed a crack and an orange sheet when he deployed the basket.The basket was removed and under direct visualization, the device was found intact.The physician went back to make sure that nothing left behind.No patient complications have been reported as a result of the event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Event Description
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It was reported to boston scientific corporation that a segura hemisphere basket was used in the ureter during a cystoscopy left ureteroscopy stone manipulation laser lithotripsy bladder biopsy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the physician noticed a crack and an orange sheet when he deployed the basket.The basket was removed and under direct visualization, the device was found intact.The physician went back to make sure that nothing left behind.No patient complications have been reported as a result of the event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Manufacturer Narrative
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Block h6: device code 4008 captures the reported event of "crack and an orange sheet when deployed the basket".Block h10: visual analysis found the basket was open when received.The sheath was found torn at the distal section.Additionally, kinks were observed on the sheath and one of the basket wires is bent/kinked.Functional inspection was performed and found the basket could not be extended/retracted when the handle was actuated, probably due to the torn sheath.Based on all available information, the failures found could have been generated by the user during manipulation/handling of the product.Once the sheath has been damaged, it will affect the functionality of the device since this type of defects do not allow the device to perform its function to move backward/forward as expected; hence, the basket section cannot be extended or retracted properly.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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