Catalog Number 0684-00-0605 |
Device Problems
Filling Problem (1233); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional reporter name: (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), an unusual amount of resistance was met while advancing to the target site of the aorta after passing through the sheath.The iab was able to be inserted, but once it was connected the console generated a continuous auto-fill failure alarm.The iab was removed and replaced with a new one, which was inserted and functioned 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 aug-19 through jul-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #510110 h3 other text : device not returned.
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Event Description
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N/a.
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Event Description
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N/a.
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Manufacturer Narrative
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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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Manufacturer Narrative
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The product was returned with the membrane loosely unfolded with blood on the exterior of the catheter.A catheter tubing kink was observed near the y-fitting at approximately 75.2cm from the iab tip.An underwater leak test of the balloon, catheter tubing, y-fitting and extracorporeal tubing was performed and no leaks were detected.The technician attempted to insert a 0.025¿ laboratory guidewire through the inner lumen and was found to be occluded with dry blood.Unable to clear the occlusion.The iab was placed on the cs300 pump for two hours, which represents one complete autofill cycle.The iab pumped, inflated normally and no alarm sounded.We were unable to duplicate the reported difficulty advancing the iab due to the returned unfolded condition of the membrane.Additionally, we are unable to duplicate the reported alarm since the iab pumped and inflated normally.Although the evaluation was unable to duplicate the reported problems, kinks to the catheter tubing may contribute to autofill failures.The reported events cannot be confirmed by the evaluation.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 aug-19 through jul-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).
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Search Alerts/Recalls
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