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Model Number M00565040 |
Device Problems
Break (1069); Difficult to Remove (1528); Positioning Problem (3009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/03/2014 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a wallflex enteral colonic stent was used in the descending colon during a colonoscopy and stent insertion procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat a 3cm lesion caused by a malignancy.Reportedly, the patient's anatomy was not tortuous.During the procedure, the physician deployed the stent; however, the stent placement was proximal to the desired location.The physician attempted to remove the stent with biopsy forceps but one of the wire loops on the distal end of the stent broke.According to the physician, the stent was not removed due to the anatomical location.The stent was left implanted to complete the procedure.The patient returned for evaluation on (b)(6) 2014 and the physician found that there were no issues of injuries on the surrounding mucosa due to the broken stent wire.The stent remains implanted and the patient is scheduled for another assessment in three months.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).The complainant indicated that the device 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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Search Alerts/Recalls
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