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Model Number 380350 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2023 |
Event Type
malfunction
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Event Description
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The passeo-14 balloon catheter was chosen for treatment of a mildly calcified lesion (70 percent stenosis degree) in a mildly tortuous part of the mid tibial artery.The affected device was introduced into the patients body and advanced to the area of interest.Once positioned, the balloon was inflated with a maximum pressure of 8 atm.Thereafter, the 0.014 inch guidewire was removed.The physician took a 3cc syringe with 0.5 ml contrast medium and 2 ml saline and injected the solution through the guidewire port during which the solution was seen to emerge from the balloon port of the affected device.
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Manufacturer Narrative
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The returned product was subjected to a detailed 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 affected balloon has been inflated and was deflated in the as returned state.Upon inflation the balloon opened normally but the pressure did not hold.A fine jet of water was seen to emerge from the distal balloon portion.Microscopic inspection revealed a pinhole about 11 mm proximal to the distal x-ray marker.In close vicinity to the pinhole scratches were observed which have likely been caused by a hard, sharp-edged object such as e.G., anatomical structure.A hub leakage as described in the event description could not be confirmed.Review of the production documentation 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 was determined.The root cause for the complaint event is most likely related to the patients anatomy.
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Search Alerts/Recalls
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