DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Catalog Number 0684-00-0604 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/04/2021 |
Event Type
Death
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Event Description
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It was reported that after two/three hours of intra-aortic balloon (iab) therapy, a leak was suspected in the balloon and it was removed.The iab catheter was removed because the blood pressure and patient condition were stable.The patient was talking with the physician; however approximately 8 hours after iab removal, the patient took a sudden turn for the worse and expired.According to the physician, the adverse event is not attributed to the iab.
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Manufacturer Narrative
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Event site postal code: (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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N/a.
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Manufacturer Narrative
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Updated fields: b4, d10, h3, h6, h10.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 blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was not a maquet product.Dried blood was observed within the stat gard sleeve.No blood was observed inside the iab catheter.The extender tubing was also returned.A kink was found on the catheter tubing approximately 36.1cm from the iab tip.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.An underwater leak test of the stat gard sheath seal, balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.A kink in the catheter tubing may cause an opening for blood to pass out of the sheath seal.However, the reported event 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.Reference complaint #(b)(4).
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