APOLLO ENDOSURGERY BIB INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
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Model Number B-40800 |
Device Problems
Material Separation (1562); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2024 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that an orbera intragastric balloon was attempted to be implanted on (b)(6) 2024.During the procedure, the sheath covering the balloon opened, and the catheter detached.The balloon was removed, and the procedure was cancelled.The procedure was rescheduled on (b)(6) 2024 at which time the balloon was successfully implanted.There were no patient complications reported for this event.
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Manufacturer Narrative
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Block h6: impact code f05: delay in treatment, therapy, captures the reportable event of initial procedure cancelled, and rescheduled.
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Search Alerts/Recalls
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