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Model Number 1601-44 |
Device Problems
Unintended Movement (3026); Failure to Deflate (4060)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/03/2022 |
Event Type
malfunction
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Event Description
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It was reported that during the pre-use check, the balloon was not able to inflate, so a different device was used for the operation.However, when the product was received it was found that the returned device had the ligature of the balloon slipped toward the distal end of the catheter, which prevented the balloon from deflating.The balloon failing to deflate can potentially cause injury to the patient or require the surgeon to manually pop the balloon to prevent injury.
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Manufacturer Narrative
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The initial report stated that the balloon was unable to inflate during the pre-use check, which was deemed a not reportable incident.Upon receiving and investigating the device on 16sep2022, the ligature was observed displaced toward the distal end of the catheter.This resulted in the balloon failing to deflate.Due to the failure, the reporting decision was updated to a reportable event.The force of pulling the catheter during the procedure caused the ligature to slip toward the distal end of the catheter.This allowed the balloon to move past the skive hole in the catheter and prevented the balloon from deflating.No stretching or necking was observed along the catheter lumen.No patient injury was reported.The lot history record for the device was reviewed, no issues were found that would cause or contribute to the reported event.Additionally, we have not received any reports of similar issues occurring for this lot.
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Search Alerts/Recalls
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