Catalog Number 0684-00-0605 |
Device Problems
Difficult to Insert (1316); Unraveled Material (1664)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Event site postal code - (b)(4).Complete event site name - (b)(4) medical center.The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id#: (b)(4).
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Event Description
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It was reported during insertion of the intra-aortic balloon (iab), the wrapping was unraveled before the balloon membrane passed through the sheath, and it did not pass through the hub of the sheath.Another iab was used to start therapy.There was no reported injury to the patient.
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Event Description
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It was reported during insertion of the intra-aortic balloon (iab), the wrapping was unraveled before the balloon membrane passed through the sheath, and it did not pass through the hub of the sheath.Another iab was used to start therapy.There was no reported injury to the patient.
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Manufacturer Narrative
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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.Reference complaint #: (b)(4).
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Event Description
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It was reported during insertion of the intra-aortic balloon (iab), the wrapping was unraveled before the balloon membrane passed through the sheath, and it did not pass through the hub of the sheath.Another iab was used to start therapy.There was no reported injury to the patient.
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Manufacturer Narrative
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The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.The sheath was not returned for evaluation.The inner lumen was found to be occluded with dried blood.The occlusion was able to be cleared.A laboratory insertion test was unable to be performed due to the membrane being unfurled.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.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.Complaint #: (b)(4).
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Search Alerts/Recalls
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