Catalog Number 0684-00-0604 |
Device Problems
Leak/Splash (1354); Difficult to Remove (1528)
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Patient Problems
Thrombus (2101); Injury (2348)
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Event Date 06/29/2019 |
Event Type
Injury
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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.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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After percutaneous cardiopulmonary support device (pcps), percutaneous coronary intervention (pci) was performed and intra-aortic balloon (iab) therapy started in a patient with acute myocardial infarction (ami).On the fifth day of balloon therapy, blood leakage was confirmed and the iab catheter was unable to be retrieved percutaneously from the patient although an attempt was made.Therefore, a surgical intervention was performed and it was entirely removed from the patient¿s body.Since thrombus appeared to adhere to the balloon of this iab catheter and observed in the patient¿s vessel as well, thrombus was percutaneously removed.The iabp therapy was discontinued.
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Manufacturer Narrative
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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 # (b)(4).
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Event Description
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After percutaneous cardiopulmonary support device (pcps), percutaneous coronary intervention (pci) was performed and intra-aortic balloon (iab) therapy started in a patient with acute myocardial infarction (ami).On the fifth day of balloon therapy, blood leakage was confirmed and the iab catheter was unable to be retrieved percutaneously from the patient although an attempt was made.Therefore, a surgical intervention was performed and it was entirely removed from the patient¿s body.Since thrombus appeared to adhere to the balloon of this iab catheter and observed in the patient¿s vessel as well, thrombus was percutaneously removed.The iabp therapy was discontinued.
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Event Description
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After percutaneous cardiopulmonary support device (pcps), percutaneous coronary intervention (pci) was performed and intra-aortic balloon (iab) therapy started in a patient with acute myocardial infarction (ami).On the fifth day of balloon therapy, blood leakage was confirmed and the iab catheter was unable to be retrieved percutaneously from the patient although an attempt was made.Therefore, a surgical intervention was performed and it was entirely removed from the patient¿s body.Since thrombus appeared to adhere to the balloon of this iab catheter and observed in the patient¿s vessel as well, thrombus was percutaneously removed.The iabp therapy was discontinued.
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Manufacturer Narrative
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Changed from: product problem to: adverse event & product problem.Changed from: malfunction to: serious injury.The iab was returned with the sheath over the catheter tubing and blood on the exterior.The extender tubing was also returned.The membrane and inner lumen within the membrane was cut from the catheter and not returned.An underwater leak test of the catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.The reported events cannot be confirmed by the evaluation.We were unable to test the complete iab for the reported iab leak and difficulty removing the iab from the patient because of the returned condition of the catheter and we are unable to mimic the clinical setting.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint # (b)(4).
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Search Alerts/Recalls
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