DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0684-00-0480-01 |
Device Problems
Difficult to Remove (1528); Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/27/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Occupation: cardiac surgeon.(b)(6).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.Complaint record id # (b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, the guidewire was difficult to remove.Once the iab was connected to the console, the arterial curve was not displayed properly.A new iab was inserted without further issue.There was no patient harm or adverse event reported,.
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Manufacturer Narrative
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The iab was returned with the membrane completely unfolded.No blood was visible on the catheter.The guide wire was returned unraveled outside of the iab.The returned guide wire was unable to be used for testing due to its returned condition.The technician attempted to insert a laboratory 0.025¿ guide wire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.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-2019 through jul-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #505346.
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