Model Number H749A70200 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/25/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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Same case as mdr id# 2134265-2018-01710 and 2134265-2018-01711.It was reported that automatic pullback failure occurred.The 70% stenosed target lesion was located in the non-tortuous and mildly calcified left anterior descending (lad) artery.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a pullback sled.During a percutaneous coronary intervention (pci) procedure, the pullback sled didn¿t perform the pullback smoothly when auto pullback was on.The physician tried to initiate the automatic pullback but it failed.The procedure was completed with another of same device.No patient complications were reported and the patient was safe.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for analysis.Device analysis revealed the sled was returned on overall good physical condition.Sled was able to properly connect to the motor drive unit 5+ (mdu5+).During functional testing using a test catheter, the sled was able to properly pull back and performed within specifications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
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Event Description
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Same case as mdr id# 2134265-2018-01710 and 2134265-2018-01711.It was reported that automatic pullback failure occurred.The 70% stenosed target lesion was located in the non-tortuous and mildly calcified left anterior descending (lad) artery.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a pullback sled.During a percutaneous coronary intervention (pci) procedure, the pullback sled didn¿t perform the pullback smoothly when auto pullback was on.The physician tried to initiate the automatic pullback but it failed.The procedure was completed with another of same device.No patient complications were reported and the patient was safe.
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Search Alerts/Recalls
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