BOSTON SCIENTIFIC - MARLBOROUGH STONE CONE NITINOL UTROLOGICAL RETRIEVAL COIL; DISLODGER, STONE, FLEXIBLE
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Model Number UNK275 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/28/2016 |
Event Type
Injury
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Manufacturer Narrative
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The complainant was unable to report the upn and lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(4).The complainant indicated that the device has been disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, 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 stone cone nitinol urological retrieval coil was used in the mid-ureter during a cystoscopy, ureteroscopy and laser lithotripsy procedure on (b)(6) 2016.According to the complainant, eight months after the procedure, the patient came back for a planned second surgery to treat another stone and a calcified portion of the stone cone from the prior procedure was found and removed.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 stable.
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