Catalog Number 0684-00-0474 |
Device Problems
Device Contamination with Chemical or Other Material (2944); Moisture or Humidity Problem (2986); Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 prior to use of the intra-aortic balloon (iab), the catheter appeared to have moisture inside the packaging.There was no patient involvement.
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Event Description
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It was reported that there were 12 intra-aortic balloons (iab) catheters from this batch that appeared to have moisture inside the packaging.There was no patient involvement.This report is for #1 of the 12 devices.
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Manufacturer Narrative
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It was reported that there were 13 intra-aortic balloons (iab) catheters from this batch that appeared to have moisture inside the packaging.There was no patient involvement.This report is for #12 of the 13 devices.It was reported that there were 12 intra-aortic balloons (iab) catheters from this batch that appeared to have moisture inside the packaging.There was no patient involvement.This report is for #1 of the 12 devices.Lot number [from] 3000076250 [to] 3000036206.The pictures provided by the customer were evaluated and a substance is visible inside one of the twelve insertion kits.Based on the photograph provided by the customer, a substance is confirmed inside one of the insertion kits.We are unable to evaluate the iab for that device, as no picture was provided.A 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).
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Event Description
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It was reported that there were 13 intra-aortic balloons (iab) catheters from this batch that appeared to have moisture inside the packaging.There was no patient involvement.This report is for #12 of the 13 devices.
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Manufacturer Narrative
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Initially reported; it was reported that prior to use of the intra-aortic balloon (iab), the catheter appeared to have moisture inside the packaging.There was no patient involvement.It was reported that there were 13 intra-aortic balloons (iab) catheters from this batch that appeared to have moisture inside the packaging.There was no patient involvement.This report is for #12 of the 13 devices.(b)(4).
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Search Alerts/Recalls
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