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Model Number M00558370 |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon was unable to be deflated all the way down and needed to be cut to be removed from the scope.The procedure was completed at this time.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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