Date of event was approximated to (b)(6) 2020 as no event date was reported.(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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It was reported to boston scientific corporation that a nephromax balloon catheter kit was used during a percutaneous nephrolithotomy (pcnl) procedure performed on an unknown date.According to the complainant, during the procedure, the balloon ruptured due to the access sheath being fragile and weak."additionaly", it was noticed that the access sheath breaks at the tip.Reportedly, the device was removed from the patient.There were no patient complications reported as a result of this event.
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