BOSTON SCIENTIFIC - MARLBOROUGH STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL; DISLODGER, STONE, FLEXIBLE
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Model Number M0063903200 |
Device Problem
Material Frayed (1262)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 stone cone nitinol urological retrieval coil was used during a calculus fragmentation/lithotripsy procedure.According to the complainant, during the procedure when the physician opened the coil of the stone cone nitinol urological retrieval coil inside the patient, it was observed that the ¿blue and coating became untwisted." the coating did not detach from the device.The physician continued to use the device and the procedure was successfully completed with this device.There were no patient complications reported as a result of this event.The patient¿s condition at the conclusion of the procedure was reported to be ¿good.¿.
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Manufacturer Narrative
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A visual analysis of the returned device revealed that the blue green heat shrink was accordion and presented peeling below the distal stop preventing the device from completely closing.Based on the condition of the returned device, the complaint was confirmed.Since the complaint is associated with a product which met specifications but most likely encountered anatomical or procedural factors which limited its performance, the most probable root cause for this event is operational context.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.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
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Event Description
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It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used during a calculus fragmentation/lithotripsy procedure.According to the complainant, during the procedure when the physician opened the coil of the stone cone nitinol urological retrieval coil inside the patient, it was observed that the "blue and green coating became untwisted".The coating did not detach from the device.The physician continued to use the device and the procedure was successfully completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be "good".
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Search Alerts/Recalls
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