Catalog Number 44038KA2/CNB |
Device Problems
Material Separation (1562); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/18/2024 |
Event Type
Injury
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Event Description
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The account alleges that during a percutaneous transluminal angioplasty [pta] procedure, the catheter tip detached within the patient.The physician had acquired retrograde arterial access and during a guidewire exchange under fluoroscopy, the catheter tip detached.The physician successfully externalized the foreign body from the patient via cut down technique liberating the vessel.No additional patient consequences to report.
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Manufacturer Narrative
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The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.
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Manufacturer Narrative
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The suspect medical device was not returned for evaluation.A photograph was provided by the account.The complaint is confirmed.The root cause is attributed to the manufacturing process.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and one similar complaint for this lot number was identified.
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Search Alerts/Recalls
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