Catalog Number 0684-00-0605 |
Device Problems
Difficult to Insert (1316); Unraveled Material (1664)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2021 |
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.Complaint record id # (b)(4).
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Event Description
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It was reported that during insertion of the intra-aortic balloon (iab), the iab membrane was unfurled and could not be passed through the sheath.A new iab was used to continue therapy without further issue.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period sep-19 through aug-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).
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Event Description
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N/a.
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Manufacturer Narrative
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The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The one-way valve was returned inside sealed packaging unused.The sheath was not returned for evaluation.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 non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period sep-19 through aug-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).
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Event Description
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N/a.
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Manufacturer Narrative
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Updated fields date of this report, return to manufacture date , device evaluated by mfg, device not eval provide code, investigation findings code, investigation conclusions code, addtl mfg narrative/corr.Data.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).
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Search Alerts/Recalls
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