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Model Number M00565120 |
Device Problem
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 12/26/2019 |
Event Type
Injury
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Manufacturer Narrative
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Patient's exact weight is unknown; however it was reported that the patient's body mass index is 27.68 kg/m2.(b)(4).The complainant indicated that the fragment was disposed of and the stent remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation on january 10, 2020 that a wallflex colonic stent has been implanted in the colon to treat an extrinsic severe stenosis measuring 1 cm in length x 7 mm in diameter located at 30 cm proximal to the anus during a gastrointestinal stent placement procedure performed on (b)(6) 2019.According to the complainant, post stent placement, the physician noticed that a part of the delivery catheter was sheared off and was left inside the stent lumen.The fragment was successfully removed with biopsy forceps and the stent remains implanted.The patient's condition at the conclusion of the procedure was reported to be fine.
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Search Alerts/Recalls
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