Model Number M0061603250 |
Device Problems
Break (1069); 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 03/22/2019 |
Event Type
Injury
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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 urinary diversion stent was implanted in the kidney and bladder for a total cystectomy procedure on an unknown date.According to the complainant, one week after the operation on (b)(6) 2019, during withdrawal, the stent was removed.It was reported that the stent was indwelled in a situation where there was a loop in the new bladder.The stent was noticed to be detached in the bladder side.The detached stent was completely removed through the use of a cystoscope.There were no adverse patient effects reported as a result of this event.
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Event Description
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It was reported to boston scientific corporation that a percuflex urinary diversion stent was implanted in the kidney and bladder for a total cystectomy procedure on an unknown date.According to the complainant, one week after the operation on (b)(6), 2019, during withdrawal, the stent was removed.It was reported that the stent was indwelled in a situation where there was a loop in the new bladder.The stent was noticed to be detached in the bladder side.The detached stent was completely removed through the use of a cystoscope.There were no adverse patient effects reported as a result of this event.
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Manufacturer Narrative
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Device problem code 2907 captures the reported event of stent detached.Investigation analysis: a percuflex urinary diversion stent was returned for analysis.A visual evaluation of the returned device revealed that the shaft was detached (both sections of the detached are stretch) near to the pigtail section.Consequently; confirming the reported complaint.The failure found (stent detached and stretch) is an issue that could have been generated by the user if the device was pulled until it was separated.Therefore, 'adverse event related to procedure' is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.Correction to initial reporter city: updated to (b)(6).Correction to initial reporter address: updated to (b)(6).Correction to initial reporter zip/post code: updated to (b)(6).
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Search Alerts/Recalls
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