Lot Number 4069274 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2021 |
Event Type
malfunction
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Event Description
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It was reported that 10 days after starting use of the product, the customer noticed that the pilot balloon was detached.No patient injury.No additional information is available for this complaint.
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Manufacturer Narrative
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Other text: additional information added to h6 and h10.This remediation mdr was generated under protocol(b)(4) as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.Inflation line detached from pilot balloon was observed and a lack of solvent was detected.No other analysis were performed.The root cause of the reported issue was found to be the most probable cause was not enough solvent at joint cause by bad condition on the feeder system equipment.Actions were taken to mitigate the reported issue: implemented immediate actions to mitigate the reported condition by improving process steps directly related with factors in the process.
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Search Alerts/Recalls
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