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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Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4) peg tube detached/separated.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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Event Description
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It was reported to boston scientific corporation that an endovive standard peg kit push method was used during a percutaneous endoscopic gastrostomy procedure.Procedure date is unknown.According to the complainant, during the procedure, the peg tube broke while it was pulled through the incision site.The procedure was completed with another endovive standard peg kit push method.The patient's condition at the conclusion of the procedure was reported to be okay.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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Search Alerts/Recalls
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