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Model Number M00565110 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/10/2014 |
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 colon during a stent placement/decompression procedure performed on (b)(6) 2014.According to the complainant, the stent was to be implanted to treat a malignant stricture.Reportedly, the patient's anatomy was not pre dilated.During the procedure, it was reported that the stent prematurely deployed causing the stent to be placed in an incorrect location.The fully deployed stent was removed from the patient and the procedure was completed with a different device.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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Pt age: exact patient age is unknown; however, the patient was reported to be over 18 years old.(b)(4).The complainant indicated that the device was disposed 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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