Model Number 001158-20D |
Device Problems
Entrapment of Device (1212); Fracture (1260); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
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Patient Problems
Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
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Event Date 03/10/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Event took place in (b)(6); date of event unknown; as soon as investigations will be finished, a follow up report will be sent in to fda.
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Event Description
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(b)(4).Tentative summarizing translation from user's narrative: upon removal of the catheter the inner coil stuck in patient's knee; possibly fragment lost within patient.
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Manufacturer Narrative
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Based on risk assessment and clinical evaluation file is considered as closed.As soon as further significant data will be available a follow up report will be sent in to the agency.We consider this file as closed.
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Event Description
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Internal report number: (b)(4).Tentative summarizing translation from user's narrative: upon removal of the catheter the inner coil stuck in patient's knee; possibly fragment lost within patient.
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Search Alerts/Recalls
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