Catalog Number 59038UAC |
Device Problems
Material Fragmentation (1261); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2021 |
Event Type
Injury
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Manufacturer Narrative
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The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
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Event Description
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The account alleges that during a fibroid embolization the physician torqued the catheter to the point it became severely twisted.In an attempt to untwist, a stiff guide wire was inserted to straighten the catheter.Without checking to make sure the catheter was straight, the catheter was pulled aggressively and detached in the distal end of the patient.The detached piece was successfully collected with a snare.No patient harm to report.
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Manufacturer Narrative
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The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned at a later date, the investigation will be re-opened.
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Search Alerts/Recalls
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