Model Number IPN923527 |
Device Problem
Failure to Deflate (4060)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/31/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).Medwatch report key/report number: (b)(4).
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Event Description
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Complaint from medwatch report.The report states that during a "right heart catheterization, when the arrow- balloon wedge pressure catheter was used, only part of the balloon would inflate, then it would not deflate properly.No known harm to patient but did delay case".Additional information states that a new catheter was inserted without issue.No report of patient harm or injury.Associated mdr 3010532612-2022-00427.
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Event Description
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Complaint from medwatch report.The report states that during a "right heart catheterization, when the arrow- balloon wedge pressure catheter was used, only part of the balloon would inflate, then it would not deflate properly.No known harm to patient but did delay case".Additional information states that a new catheter was inserted without issue.No report of patient harm or injury.Associated mdr 3010532612-2022-00427.
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Manufacturer Narrative
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Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Search Alerts/Recalls
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