Model Number 0684-00-0480-01 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Complete initial reporter name - (b)(6).The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint #: (b)(4).
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Event Description
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It was reported that upon opening the intra-aortic balloon catheter, the iab was kinked.There was no reported adverse event or injury to the patient.
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Manufacturer Narrative
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The product was returned with the membrane completely unfolded and traces of blood found on the exterior of the catheter.Two kinks were found on the inner lumen and catheter tubing near the y-fitting approximately 67.3 and 76.2cm from the iab tip.The evaluation confirmed the kinks in the catheter.We are unable to determine when this may have occurred.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint # (b)(4).
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Event Description
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It was reported that upon opening the intra-aortic balloon catheter, the iab was kinked.There was no reported adverse event or injury to the patient.
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Search Alerts/Recalls
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