Model Number IPN000252 |
Device Problems
No Device Output (1435); Off-Label Use (1494); Failure to Zero (1683)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported by a teleflex sales rep.That an intra-aortic balloon (iab) fiber optic failure occurred.As a result, a new catheter was inserted via the axillary approach.There was no report of patient injury or consequence.This report would not be likely to cause or contribute to a death or serious injury.A fiber optic sensor (fos) not connecting cannot in itself cause or contribute to a patient death or serious injury.The fos is a portion of the catheter that monitors the patient's arterial pressure.When the fiber optic pressure signal is not available, the intra-aortic balloon (iab) is still able to be used since an arterial pressure signal is available through the central lumen.Iab therapy continues to the patient uninterrupted.This system does not require the clinician to remove the iab in the event that the fos is lost.It was reported that the patient was going for a heart transplant.The iab would be inserted axillary approach.Per the instructions for use (ifu) this is an off label approach.
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Manufacturer Narrative
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Qn#(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab fos would not zero is not able to be confirmed.The root cause of the complaint is undetermined.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
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Event Description
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It was reported by a teleflex sales rep.That an intra-aortic balloon (iab) fiber optic failure occurred.As a result, a new catheter was inserted via the axillary approach.There was no report of patient injury or consequence.This report would not be likely to cause or contribute to a death or serious injury.A fiber optic sensor (fos) not connecting cannot in itself cause or contribute to a patient death or serious injury.The fos is a portion of the catheter that monitors the patient's arterial pressure.When the fiber optic pressure signal is not available, the intra-aortic balloon (iab) is still able to be used since an arterial pressure signal is available through the central lumen.Iab therapy continues to the patient uninterrupted.This system does not require the clinician to remove the iab in the event that the fos is lost.It was reported that the patient was going for a heart transplant.The iab would be inserted axillary approach.Per the instructions for use (ifu) this is an off label approach.
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Search Alerts/Recalls
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