Catalog Number 56535RIM |
Device Problems
Fracture (1260); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2022 |
Event Type
Injury
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Event Description
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The account alleges that during an interventional percutaneous transhepatic biliary drainage/stenting procedure, the 4f catheter tip detached within the patient when the physician was trying to maneuver the catheter across the biliary artery.The foreign body was left behind within the patient's vascular system.The patient is scheduled for an additional foreign body removal procedure.
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Manufacturer Narrative
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The suspect device is expected to return for evaluation.A follow-up report will be submitted once the evaluation has been complete.
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Manufacturer Narrative
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The suspect medical device was not returned for investigation.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 later, the investigation will be reopened.
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Search Alerts/Recalls
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