Model Number A496162 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
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Event Description
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During procedure right after a placement of the introducer sheath in vessel, a physician found blood leak from the hemostasis valve.The product was replaced with an additionally opened a496162, and the procedure was completed.
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Manufacturer Narrative
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A review of the dhr and inspection records could not be conducted since there was no lot number provided by the customer.One opened sample was returned for review from the customer.A functional test was performed on the returned sample.The inspection established that the introducer with the side port and the stopcock showed no visible external damage.The parts were flushed with water, colored water and there was no leakage found in the side port or the dilator during the time of inspection.The failure could not be duplicated.Since the failure mode could not be duplicated, no root cause or corrective action is necessary at this time.
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Event Description
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During procedure right after a placement of the introducer sheath in vessel, a physician found blood leak from the hemostasis valve.The product was replaced with an additionally opened a496162, and the procedure was completed.
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Event Description
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During procedure right after a placement of the introducer sheath in vessel, a physician found blood leak from the hemostasis valve.The product was replaced with an additionally opened a496162, and the procedure was completed.
|
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Manufacturer Narrative
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The sample is indicated as returned.As of the date of this report, the sample has not been investigated.A follow-up report will be provided once the device has been reviewed.
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Search Alerts/Recalls
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