Catalog Number UNKNOWN |
Device Problems
Migration or Expulsion of Device (1395); Material Separation (1562)
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Patient Problem
No Code Available (3191)
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Event Date 04/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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Common name and product code = unavailable as the device lot number, rpn, and gpn are unknown.(b)(4).Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
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Event Description
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A sus report was received (mw5076991), which reported a gunther inferior vena cava filter (product identifiers unknown), that had been placed on (b)(6) 2007, fractured and migrated to the patient's right ventricle.The complaint device was reportedly surgically removed on (b)(6) 2018.A follow up was performed with the complainant who initially reported the event, there is no further information available regarding this incident.
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Manufacturer Narrative
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Investigation - evaluation a review of the complaint history, instructions for use (ifu), and specifications was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.Refer to h10 for investigational findings.
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Search Alerts/Recalls
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