Model Number 0684-00-0498-01 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Complete event site 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 the intra-aortic balloon (iab) could not be inserted through the sheath.A new iab was inserted successfully to continue therapy.There was no patient harm or adverse event reported.
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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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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 traces of blood on the exterior of the catheter with the one-way valve attached.The sheath was not returned for evaluation.A kink was found on the catheter tubing and inner lumen near the y-fitting approximately 75.9cm from the iab tip.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 and the catheter tubing and inner lumen kinked.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.The condition of the iab as received indicated a kink on the catheter tubing and inner lumen.A kink in the inner lumen can cause difficulty during insertion.We are unable to determine when the kink may have occurred.The evaluation confirmed the reported problem.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 nov-2019 to oct-2021 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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Search Alerts/Recalls
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