Model Number UHP7588 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Renal Failure (2041)
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Event Date 09/23/2021 |
Event Type
malfunction
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Event Description
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Customer reports when inflating balloon to 22psi, which was the target, the balloon burst at 21 psi.There was no patient injury reported.Minor procedural delayed was report while the new device was prepped and inserted.The new device was used to complete the procedure.
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Manufacturer Narrative
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While attempting to use device, pn: uhp7588, during an angioplasty procedure, the customer reported a balloon malfunction while inflating the balloon to target pressure of 22 psi, the balloon burst at 21 psi.The device, pn: uhp7588, was removed with no further issues.A new device was prepped and used to complete the procedure with minor procedural delay experienced.There was no harm to the patient reported.
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Manufacturer Narrative
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Follow up report for additional information not known at the time of original report, such as, investigation type, findings, and conclusion.
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Event Description
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Follow up report for (b)(4); mfr report #: 3005994106-2022-00002.
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Search Alerts/Recalls
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