Model Number 001158-20B |
Device Problems
Material Rupture (1546); Material Split, Cut or Torn (4008)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
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Event Date 02/07/2019 |
Event Type
Injury
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Manufacturer Narrative
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Event took place in (b)(6) and has been reported through (b)(4) distributor (b)(4).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).Summarizing tentative translation from initial reporter´s narrative: at the remove of the catheter, the user tried at 3 times to remove, the catheter stayed blocked.After this insistence, the catheter has been broken.A no determinate longueur catheter is stayed inside the patient.
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Event Description
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Irn#: (b)(4).Summarizing tentative translation from initial reporter´s narrative: at the remove of the catheter, the user tried at 3 times to remove, the catheter stayed blocked.After this insistence, the catheter has been broken.A no determinate longueur catheter is stayed inside the patient.
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Manufacturer Narrative
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The available data still is poor and the device has been disposed.Based on risk assessment and clinical evaluation report as well as substantiated by post market data this case is considered as closed.
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Search Alerts/Recalls
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