Catalog Number SR-0T1664C |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 01/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient identifier - requested but not provided.Age and date of birth - requested but not provided.Sex - requested but not provided.Weight - requested but not provided.Ethnicity - requested but not provided.Race - requested but not provided.Lot number- requested but unknown.Expiration date - requested but not provided.Udi - requested but not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - requested but not provided.The actual device was not returned to the manufacturing facility.Therefore, the investigation was limited to information provided by the user facility and review of quality records.A review of the manufacturer inspection record from the past five (5) years was conducted with no relevant findings.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).All available information has been placed on file in quality assurance for tracking, trending, and follow up.
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Event Description
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The user facility reported catheter damage in this event.Follow up communication with the user facility reported the following information: when thoracentesis was done in a patient, catheter tip was damaged.The patient is bedridden, the doctor comprehensive made his decision not to conduct surgical removal.It was reported that the patient is currently being monitored.Fragment is considered to still being remained in the patient.Additional information was received on 2/8/2018: it was reported that it was unknown if the device fragment is in the patient.
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Manufacturer Narrative
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This report is being submitted as follow up no.1 to provide corrections to sections d1 and d2 as the information that was initially submitted was inadvertently reported incorrectly.
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Search Alerts/Recalls
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