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A patient of undisclosed gender and age underwent an ercp procedure in which the oasis one action stent introduction system, g25380, was used.The stent was placed over the guide wire.035x260 boston scientific dreamwire, and advanced down the scope, olympus tjf-q180.The stent would not come out of the scope.The physician used a sohendra stent retriever and pushed the stent out of the distal and into the patient.The stent was then retrieved from the patient.The procedure was completed by placing a fusion oasis 10x7 stent.1.Did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.2.Was the patient hospitalized or was there prolonged hospitalization? no.3.Did the patient require any additional procedures due to this occurrence? no.If yes, please describe.4.Did the product cause or contribute to the need for additional procedures? no.If yes, please specify additional procedures and provide details.5.Has the complainant reported any adverse effects on the patient due to this occurrence? no.6.Has the complainant reported that the product caused or contributed to the adverse effects? no.Please specify adverse effects and provide details.2.1 for all complaints, ask: 2.1.1 does the complaint relate to: device placement this one.Device removal.Observation prior to patient contact.2.1.2 what was the target location for the stent? common bile duct.2.1.3 please describe the storage conditions of the device prior to use especially those pertaining to temperature and light exposure.Stored in a cabinet.2.1.4 *what is the reorder number, diameter and length of the wire guide that was used with this device in this procedure?*.035x260 boston scientific dreamwire.2.1.5 was the wire guide lubricated prior to use? no.2.1.6 *was the wire guide inspected for damage prior to use? no.2.1.7 was the device at the center of the complaint inspected for damage prior to use? no.2.1.8 were previous procedures i.E.Sphincterotomy etc.Carried out prior to placing the complaint device? yes- sphincterotomy.¿ if yes, please indicate the procedure performed.2.1.9 did the patient involved exhibit altered anatomy or tortuous anatomy? yes- tortuous 2.1.10 * if not with the device in question, how was the procedure finished?* placed a fusion oasis with a 10x7 stent.2.1.11 what intervention (if any) was required? stent got stuck in endoscope & was pushed into the patient with the sohedra and then retrieved from the patient.2.1.12 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? same procedure.2.1.13 were any other defects observed on the device prior to return (other than the reported complaint issue? the stent looked a bit damaged, and the introducer is acratched.If yes, please detail any other defects observed.2.2 for complaints occurring during use (once in contact with endoscope) also ask: 2.2.1 had a sphincterotomy been performed prior to this occurrence? yes.2.2.2 what is the endoscope manufacturer, the model number and working channel size that was used for the procedure? olympus jf-q180.2.2.3 does your medical facility have a service/maintenance schedule associated with its endoscopes? no but the district manager has requested they check scope such as the elevator, etc to endure it works properly.2.2.4 please indicate the location in the body where the stent device was to be placed.I.E.Biliary duct, pancreatic duct, other.Common bile duct.¿ if other, please specify.2.2.5 *was resistance encountered when advancing the wire guide to the target location? no.2.2.6 *was resistance encountered when advancing the introduction system in place to the target location? no issues until stent got stuck at distal end of scope.¿ how did the physician deal with this resistance? 2.2.7 how did the physician determine the length of the stent to be used for the procedure? patient had a bio leak & physicians go to size is 10x7.2.2.8 where was the stricture located in the duct? no stricture.2.2.9 *was the stricture dilated prior to placing the device?* no stricture.¿ if so, please indicate what device(s) were used.2.2.10 *was resistance encountered when advancing the stent through the obstructed area? no stricture.2.2.11 after placement, was stent position verified? n/a stent was not placed.¿ if yes, please describe how.2.2.12 please estimate the amount of time the stent was in place prior to this occurrence.This was during the initial placement procedure.2.2.13 did any section of the device detach inside the endoscope or patient? yes stent was stuck in distal end of scope- but it did not break.Stent was intact.¿ if yes, please specify what section of the device broke off: 2.2.14 please indicate whether the device broke in the endoscope or in the patient.Stent got stuck in distal end of endoscope 2.2.15 was the broken device retrieved? it was not broke but the stent was pushed into the patient and then retrieved.¿ if yes, please indicate what tools were used during retrieval (e.G.Basket, balloon, snare, forceps etc.): sohendra retriever.2.2.16 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: 2.2.17 please indicate why the modifications were necessary.N/a.2.2.18 please indicate any other endoscopic accessories (if any) that came into contact with the stent or introduction system during the procedure.Stent retriever 2.2.19 did the patient require any additional procedures as a result of this event? after the stent was pushed into the patient it was retrieved.2.2.20 what intervention (if any) was required? stent was retrieve from patient.2.2.21 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? same procedure.2.2.22 were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? none.¿ if yes, please specify what was observed and where on the device it was observed.
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Device evaluation: 1 x oacl-10-7 of lot number c1877706 was returned to cirl for evaluation.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 11 march 2022.The stent was returned with pushing catheter, guiding catheter and straightener.The stent was returned in the correct orientation and no damage was noted.Image review: n/a.Documents review including ifu review: prior to distribution all oacl-10-7 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 the oacl-10-7 device 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 c1877706.The instructions for use, ifu0096 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 that the use did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the lab evaluation as no damage or defect was noted on the stent and it functioned as expected.A possible root cause could be attributed to user technique where excessive force was applied to place the stent and overcome the resistance that was encountered.Summary: complaint is based on customer testimony.According to the information reported, 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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