This occurred in two different cases with different patients.In both cases the tethers broke off.For the first case, the physician placed the stent and then continued to do a resection or cauterization of the patient's urethra after the stent placement.The tether was still attached at the time.The tether later broke sometime after the patient left the hospital.The physician initially thought that he might have damaged the tether during the resection or cauterization process but later reconsidered after a second tether break was reported (1820334-2015-00823).A second stent was placed in a different patient and the tether was extending out normally.The patient called the facility a few days after the procedure to report that the tether had broken and had come out on its own (1820334-2015-00824).The stents had to be removed with flexible forceps and a cystoscope from the bladder.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Lot # requested but not provided.(b)(4).Event evaluation: a review of complaint history, instructions for use (ifu), manufacturing instructions, quality control and trends was conducted during the investigation.No product or photos were returned to assist with this investigation.The device is inspected to ensure that the tether has proper placement, suture, and a secure knot there is no evidence to suggest that the device was not manufactured to specification.The ifu details: "the stent may be removed easily by gentle withdrawal traction using endoscopic forceps." based on the information provided, the root cause is unable to be determined or reported at this time.We will continue to monitor for similar complaints.
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This occurred in two different cases with different patients.In both cases the tethers broke off.For the first case, the physician placed the stent and then continued to do a resection or cauterization of the patient's urethra after the stent placement.The tether was still attached at the time.The tether later broke sometime after the patient left the hospital.The physician initially thought that he might have damaged the tether during the resection or cauterization process but later reconsidered after a second tether break was reported (1820334-2015-00823).A second stent was placed in a different patient and the tether was extending out normally.The patient called the facility a few days after the procedure to report that the tether had broken and had come out on its own (1820334-2015-00824).The stents had to be removed with flexible forceps and a cystoscope from the bladder.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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