Catalog Number IAB-06850-U |
Device Problem
Material Rupture (1546)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/26/2024 |
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 "balloon rupture".Additional information states " two catheters were used on this patient, one from getinge and one from arrow.Not sure which was used first,but both had ruptures".Patient complications or injury unknown.Patient current condition unknown.At the time of this report, the customer has not returned our requests for additional information.
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Event Description
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It was reported "balloon rupture".Additional information states " two catheters were used on this patient, one from getinge and one from arrow.Not sure which was used first,but both had ruptures".Patient complications or injury unknown.Patient current condition unknown.At the time of this report, the customer has not returned our requests for additional information.
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Manufacturer Narrative
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Qn#(b)(4).The reported complaint for iab "balloon rupture" was not able to be confirmed as the product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.
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Search Alerts/Recalls
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