Catalog Number 0684-00-0575 |
Device Problems
Difficult to Insert (1316); Unraveled Material (1664)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Additional initial reporter - (b)(6), assistant nurse manager.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.(b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) insertion, the balloon was opened and removed from the t-handle.The customer noticed the iab was not properly wrapped and there was difficulty to insert iab through the sheath.The iab was replaced to continue 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); record id (b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) insertion, the balloon was opened and removed from the t-handle.The customer noticed the iab was not properly wrapped and there was difficulty to insert iab through the sheath.The iab was replaced to continue therapy.There was no reported injury to the patient.
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Manufacturer Narrative
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The iab was returned with the membrane completely unfolded with the one-way valve attached.No blood was visible on the catheter.The sheath was not returned for evaluation.The one-way valve was vacuum tested and it held vacuum.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.An evaluation of the product was unable to duplicate the reported problem.The product performed according to specification.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.Reference complaint #: (b)(4); record id: (b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) insertion, the balloon was opened and removed from the t-handle.The customer noticed the iab was not properly wrapped and there was difficulty to insert iab through the sheath.The iab was replaced to continue therapy.There was no reported injury to the patient.
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Search Alerts/Recalls
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