BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 6/120/135; STENT, SUPERFICIAL FEMORAL ARTERY
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Model Number 366839 |
Device Problem
Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2024 |
Event Type
malfunction
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Event Description
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A pulsar-18 peripheral artery stent system was selected for treatment of a severely calcified lesion in the mid sfa.The device was delivered to the lesion, but the stent could not be released.Even after unpacking the handle, it still could not be released.Another stent 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 for the product detailed above confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations, no material or manufacturing related root cause could be identified.It should be noted that, according to the ifu, the user is advised to remove the complete system from the patient in case the trigger release mechanism fails before releasing the stent.
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Search Alerts/Recalls
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