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A metal wire puncture the tip of the guiding catheter; we found out this wire is an extra wire never seen before in this product, it¿s independent from the stilete.Patient not injured.It will not be notification to any regulatory authority.Patient not died.They finish the procedure with a new one."as per cc form": introducing the plastic stent, the nurse took the stilete (orange cap) 4-5 cm and when she introduced it back again a stiff cable puncture the catheter.See pictures provided for this complaint.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence does the complaint relate to device replacement, device removal or was it an observation made prior to patient contact? it was in the procedure, trying to place the plastic stent what was the target location for the stent? cbd.Please describe the storage conditions of the device prior to use especially those pertaining to temperature and light exposure.N/a.What is the reorder number, diameter and length of the wire guide that was used with this device in this procedure?* n/a.Was the wire guide lubricated prior to use? n/a.Was the wire guide inspected for damage prior to use?* n/a.Was the device at the centre of the complaint inspected for damage prior to use? yes.Were previous procedures i.E.Sphincterotomy etc.Carried out prior to placing the complaint device? yes.If yes please indicate the type of procedure performed.Cbd stent placement.Did the patient involved exhibit altered anatomy or tortuous anatomy? n/a.If not with the device in question, how was the procedure finished?* opened a new one of the same ref.Number.Did the patient require any additional procedures as a result of this event? no.What intervention (if any) was required? none.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? same procedure.Were any other defects observed on the device prior to return (other than the reported complaint issue)? no.If yes, please detail any other defects observed.For complaints occurring during use (once in contact with endoscope) also ask: had a sphincterotomy been performed prior to this occurrence? yes.What is the endoscope manufacturer, the model number and working channel size that was used for the procedure? olympus tjfq180v.Does your medical facility have a service/maintenance schedule associated with its endoscopes? n/a.Please indicate the location in the body where the stent device was to be placed.I.E.Biliary duct.If other, please specify: was resistance encountered when advancing the wire guide to the target location?* n/a, was resistance encountered when advancing the introduction system in place to the target location?* n/a.How did the physician deal with this resistance? n/a.How did the physician determine the length of the stent to be used for the procedure? n/a.Where was the stricture located in the duct? n/a.Was the stricture dilated prior to placing the device?* if so, please indicate what device(s) were used.N/a.Was resistance encountered when advancing the stent through the obstructed area?* n/a.After placement, was stent position verified? n/a.If yes, please describe how.Please estimate the amount of time the stent was in place prior to this occurrence.N/a.Did any section of the device detach inside the endoscope or patient? no.If yes, please specify what section of the device broke off: please indicate whether the device broke in the endoscope or in the patient? n/a, endoscope, patient; they pulled out of endoscope.Was the broken device retrieved? yes.If yes, please indicate what tools were used during retrieval (e.G.Basket, balloon, snare, forceps etc.): just pulling.Were any modifications made to the complaint device or accessories used with the device in this procedure? (e.G.Guiding catheter shortened, stent cut etc.) no.If yes, please indicate what modifications were made: please indicate why the modifications were necessary.N/a.Please indicate any other endoscopic accessories (if any) that came into contact with the stent or introduction system during the procedure.Did the patient require any additional procedures as a result of this event? no.What intervention (if any) was required? n/a.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? no.If yes, please specify what was observed and where on the device it was observed.* not applicable if problem occurred at removal.
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Cancellation follow up report is being submitted following receipt of investigation conclusion.No adverse effect to the patient was reported as occurring.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.The overall risk associated with failure mode assigned is low.Low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.The fs-oa-10 device of lot number c1865945 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 13th jan 2022.On evaluation of the device a metal wire was protruding from the tip of the catheter approximately 5 cm from the silver marker.Metal observed to be moveable.Prior to distribution fs-oa-10 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for fs-oa-10 of lot number c1865945 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1865945.It should be noted that the instructions for use (ifu0096-1) states the following: ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working conditions, do not use¿.There is no evidence to suggest the user did not follow the ifu.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.Based on the information that¿s available the possible cause would be that the physician applied excess pressure.Summary complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
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