Model Number 0431157-51 |
Device Problems
Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017); Torn Material (3024); Device Handling Problem (3265)
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Patient Problems
Foreign Body In Patient (2687); No Information (3190)
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Event Date 10/31/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.
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Event Description
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(b)(4).Tentative summarizing translation of initial reporter´s narrative: after placement of catheter and upon removal of the distal cap (?) the coil was torn out of the catheter.
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Manufacturer Narrative
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Based on risk assessment and clinical evaluation file is considered as closed.
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Event Description
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(b)(4).Tentative summarizing translation of initial reporter´s narrative: after placement of catheter and upon removal of the distal cap (?) the coil was torn out of the catheter.
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Search Alerts/Recalls
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