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Model Number IPN038077 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2023 |
Event Type
malfunction
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Event Description
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It was reported that, "highly torturous femoral artery, the sheath and the shaft of iabp was kinked and the balloon was not inflating, balloon was removed as bp was not displayed".Additional information states that a 2nd iab was used and inserted at the same insertion site.No harm or injury to the patient.The patient status is reported as "fine".
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Manufacturer Narrative
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Qn# (b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
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Manufacturer Narrative
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(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.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that, "highly torturous femoral artery, the sheath and the shaft of iabp was kinked and the balloon was not inflating, balloon was removed as bp was not displayed".Additional information states that a 2nd iab was used and inserted at the same insertion site.No harm or injury to the patient.The patient status is reported as "fine".
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Search Alerts/Recalls
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