DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0684-00-0296-02 |
Device Problems
Leak/Splash (1354); Difficult to Remove (1528)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Occupation: administrator/ supervisor.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).Device not returned.
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, a balloon rupture occurred.The insertion was reported to be axillary, which is not the method described in the device instructions for use.Upon removal, it was noted that the ruptured iab was crumpled and became difficult to remove.The patient required a larger incision to remove the iab.A new iab was inserted to continue therapy.
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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 ruptured with heavy blood in the membrane, on the exterior, extracorporeal tubing, between the sheath and catheter tubing.The sheath was returned at approximately 1.2cm from the iab tip and covered ¾ of the balloon.The sheath was unable to be removed from the iab.The inner lumen was broken at approximately 26.6 cm from the iab tip.An underwater leak test of the catheter, y-fitting, extracorporeal tubing, was performed and no leaks were detected.A leak test of the membrane and inner lumen was unable to be performed.A 0.0025¿ guidewire was inserted and the inner lumen was found to be occluded with blood and unable to be cleared.The evaluation confirmed the reported problems.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This may have contributed to the reported failure.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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Event Description
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N/a.
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Search Alerts/Recalls
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