Device evaluation: 01 x zebd-7-12 zimmon biliary stent set of lot number c2018481 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document-based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on (b)(6)2023.The lab evaluation notes, and lab attendees can be verified in the ¿returned product-notes ¿section.The returned device lab examination findings and observations can be referred through attached files.On evaluation it was noted that positioner and stent returned, no pigtail straightener returned.Kink observed on the 3rd, 4th & 5th porthole on the tapered end.Compression damage on the non-tapered end of the stent, end of stent deformed.Kinks observed on the 2nd and 3rd porthole, severe kink on 4th porthole of the non-tapered end.A 0.035" wire guide does not pass the kinks.Manufacturing records review: prior to distribution all devices are subjected to visual and functional checks to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use /or label review: the instructions for use, (ifu0045) which accompanies this device instructs the user to ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ there is no evidence to suggest the customer did not follow the instructions for use.Image review: as per image provided, single pigtail plastic stent can be seen within the tyvek pouch.Due to the position of the map 80 label covering the majority of the stent it is not possible to see the damage on the stent.Root cause analysis: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.Also, due to limited information received on this file as several attempts were made and no information was provided by the customer to assist in with identifying the complaint failure reported only a possible root cause can be assumed.A possible root cause could be attributed to the user applying excessive force during straightening of the pigtail curl, therefore causing the kinks and the compression damage noted on the stent which in turn lead to difficulty advancement into the endoscope.Confirmation of complaint: the complaint confirmed based on visual and/or functional inspection.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: failure identified: multiple kinks on tapered end of stent.Compression damage and severe kinks on the non-tapered end of the stent, end of stent deformed, confirmed quantity of 01 device reported used.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to user applying excessive force during straightening of the pigtail curl, therefore causing the kinks and the compression damage noted on the stent which in turn lead to difficulty advancing and placing the stent.The complaint confirmed based on visual and/or functional inspection.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.
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