BARD ACCESS SYSTEMS, INC. POWERPICC PROVENA 4 FR CATHETER WITH SHERLOCK 3CG TIP; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Model Number S1274108D |
Device Problems
Break (1069); Entrapment of Device (1212); Difficult to Advance (2920); Material Twisted/Bent (2981)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 04/27/2022 |
Event Type
malfunction
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Event Description
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Difficulty advancing guidewire noted during picc insertion.Guidewire removed and kinks noted.Picc line placed and x-ray used for confirmation d/t tip confirmation system not working correctly.Initial x-ray confirmed picc placed in correct position, along with a small object that could be broken piece of guidewire.Radiologist confirmed a 1.9 cm thin linear radiodensity overlying the right axilla.Patient sent to ir for retrieval, which was unsuccessful d/t broken fragment migrating to tricuspid valve.Decision made to not attempt retrieval due to risk.Patient asymptomatic at this time.Fda safety report id# (b)(4).
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