BOSTON SCIENTIFIC - MARLBOROUGH ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
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Model Number UNK518 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The complainant indicated that the device will not be returned; 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 that an endovive initial placement kit was used during a percutaneous endoscopic gastrostomy procedure.The procedure date is unknown.According to the complainant, the internal bolster detached and was found at the duodenum level.This event was noticed upon annual changed of the tube.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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Event Description
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It was reported to boston scientific corporation that an endovive initial placement kit was used during a percutaneous endoscopic gastrostomy procedure.The procedure date is unknown.According to the complainant, the internal bolster detached and was found at the duodenum level.This event was noticed upon annual changed of the tube.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information as of march 23, 2017.The peg tube reported in the above event was not a bsc device as originally reported.
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Search Alerts/Recalls
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