BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X12CM; CATHETER, CONTINUOUS FLUSH
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Model Number 500-55112 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/31/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Device media analysis: an ekosonic endovascular device was returned for analysis with the cord cut.The ultrasonic core (usc) from this kit was not returned.During decontamination, the device was observed to have significant leakage from the luer ports to both the drug line and coolant line.Visual inspection revealed a kink in the catheter at 45cm from the manifold.The device was able to be flushed through the manifold luer with no apparent clogging.Microscopic visual inspection of the exterior of the catheter confirmed that both the drug and coolant luer ports were significantly cracked.Potential clogs were also noted in some of the drug holes.Although potential clogs were noted in some of the drug holes, due to the significant cracking of the luer ports, the drug line was unable to be properly flushed and the reported event of clogging could not be confirmed.
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Event Description
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Reportable based on device analysis completed on (b)(6) 2022.It was reported that the catheter was clogged following an overnight placement.An ekosonic endovascular device, 106x12cm was selected for use.The ekos catheter was placed in the patient and infusion began immediately.The patient was transferred to the icu for treatment overnight.In the morning, it was observed that the catheter was clogged.It was undetermined whether the clog was within the drug line or the coolant line.No pump alerts were reported.The catheter was removed from the patient and treatment was concluded at that time.There were no reported adverse consequences to the patient.However, device analysis revealed the drug line was clogged.
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