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Description of event
the physician reported a cumulative total of 3 cases where the distal pigtail repeatedly eroded against the duodenal wall, causing duodenal ulcers.Patients began experiencing pain approximately one month post-placement, forcing the physician to perform premature stent removal.Currently, this stent is only available in a single thickness of 10fr, with no other size options provided.It is unclear whether this issue stems from the product design (e.G., pigtail configuration/size) or material hardness (e.G., high durometer causing tissue erosion).Therefore, the physician has submitted a formal product complaint requesting a full investigation by the manufacturer.Patient/event info - notes
triage requested - (b)(6)2026:
1.Please describe the storage conditions of the device prior to use especially those pertaining to temperature and light exposure.Room temperature 25 °c, storage in closet.2.What is the reorder number, diameter and length of the wire guide that was used with this device in this procedure?
this problem occurred during the period of stenting.There were no reorder stent.3.Was the wire guide lubricated prior to use? "[n/a, yes, no]"
yes.4.Was the wire guide inspected for damage prior to use? "[n/a, yes, no]"
no
5.Was the device at the center of the complaint inspected for damage prior to use? "[n/a, yes, no]"
no
6.Were previous procedures i.E., sphincterotomy etc.Carried out prior to placing the complaint device? "[n/a, yes, no]"
(if yes, please indicate the procedure performed.)
yes, they did sphincterotomy.7.Did the patient involved exhibit altered anatomy or tortuous anatomy? "[n/a, yes, no]"
no
8.Were any other defects observed on the device prior to return (other than the reported complaint issue? "[yes, no]"
(if yes, please detail any other defects observed.)
no
9.What is the endoscope manufacturer, the model number and working channel size that was used for the procedure?
olympus tjf260
10.Does your medical facility have a service/maintenance schedule associated with its endoscopes? "[n/a, yes, no]"
no
11.Was resistance encountered when advancing the wire guide to the target location? "[n/a, yes, no]"
no
12.How did the physician determine the length of the stent to be used for the procedure?
to pass the stricture.13.Where was the stricture located in the duct?
in chd.14.Was the stricture dilated prior to placing the device?
(if so, please indicate what device(s) were used.)
no
15.After placement, was stent position verified? "[n/a, yes, no]"
(if yes, please describe how)
the stent migrated after placing for around 2 months.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.) "[n/a, yes, no]"
(if yes, please indicate what modifications were made:)
no
17.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G., kink)? "[n/a, yes, no]"
(if yes, please specify what was observed and where on the device it was observed.)
no
additionally, (b)(4)references "three cases" but only one complaint form (containing patient-specific information) is available:
are complaint form's available for the 2 other cases referenced?
no.
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