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Model Number M0061752730 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(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 percuflex plus ureteral stent was open to be used during a holmium laser lithotripsy procedure in the ureteral calculus performed on (b)(6) 2020.According to the complainant, when the physician unpacked the device, it was noticed that the device was fractured.Reportedly the procedure was completed.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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Search Alerts/Recalls
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