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Model Number 502402B |
Device Problems
Entrapment of Device (1212); Mechanical Jam (2983)
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Patient Problems
Cardiac Perforation (2513); Pericardial Effusion (3271)
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Event Date 11/15/2022 |
Event Type
Injury
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Event Description
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Patient undergoing right heart cath with multiple myocardial biopsies.Biopsy forceps tested prior to use, was functioning appropriately.Two biopsies were obtained without difficulty.The third biopsy sample was obtained, the locking mechanism would not release the forceps.The patient required transfer to the or for removal.Two attempts to release the locking mechanism were made by cutting the coaxial cable which were unsuccessful.The forceps had to be pulled from the myocardial tissue causing a portion of the myocardium to be extracted with the forceps leading to a pericardial effusion.
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Event Description
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Patient undergoing right heart cath with multiple myocardial biopsies.Biopsy forceps tested prior to use, was functioning appropriately.Two biopsies were obtained without difficulty.The third biopsy sample was obtained, the locking mechanism would not release the forceps.The patient required transfer to the or for removal.Two attempts to release the locking mechanism were made by cutting the coaxial cable which were unsuccessful.The forceps had to be pulled from the myocardial tissue causing a portion of the myocardium to be extracted with the forceps leading to a pericardial effusion.
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Search Alerts/Recalls
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