Model Number 561187-31A |
Device Problems
Detachment Of Device Component (1104); Fracture (1260); Difficult to Remove (1528); Device Issue (2379); Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919); Mechanical Jam (2983)
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Patient Problems
Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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Event Date 05/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Event took place in (b)(6) and has been reported through (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).User's narrative: at the removal of the needle, the catheter was dissociated of his elocal coil.A 10cm of catheter got stuck in the body of the patient.The surgeon tried to take off the catheter without success.Patient received antibiotic and he remained under observation.
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Manufacturer Narrative
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Based on risk assessment and clinical evaluation file is considered as closed.Not returned.
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Event Description
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(b)(4).At the removal of the needle, the catheter was dissociated of his elocal coil.Ten cm of cathter is got stuck in the body of the patient.The surgeon tried to take off the catheter without success.Patient received antibiotic and he remained under observation.
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Search Alerts/Recalls
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