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Model Number 419153 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Combination product: yes.
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Event Description
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An orsiro mission drug-eluting stent system was selected for treatment of the lad.Despite pre-dilatation of the lesion, the balloon ruptured at 16 bar.
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Manufacturer Narrative
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Combination product: yes the returned product was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation of the returned instrument revealed that the balloon has been inflated and was deflated in the as-returned state.Upon inflation a fine jet of water was seen to emerge from the proximal part of the balloon.Microscopic inspection revealed a small pinhole in the balloon surface about 13 mm distal to the proximal x-ray marker.Scratches were observed in close vicinity of the pinhole.Review of the production documentation confirmed that the instrument 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 helium leak test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause is most likely related to the patients anatomy.
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Search Alerts/Recalls
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