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Model Number 366134 |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2023 |
Event Type
malfunction
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Event Description
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A passeo-18 peripheral balloon catheter was selected for treatment of a severe stenosis (70 percent stenosis degree) in the left sfa.After pre-dilatation with a smaller passeo-18, the complaint passeo-18 was used, but the balloon could not be inflated after it reached the lesion.The pressure was very low and did not record.Another device was used to finish the procedure.
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Manufacturer Narrative
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Neither the affected device nor the angiographic material was returned.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a pressure test and a helium leak test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations, no material or manufacturing.Related root cause could be determined.
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Search Alerts/Recalls
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