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Model Number N/A |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Patient identifier: requested, not provided, weight: requested, not provided, ethnicity: requested, not provided, race: requested, not provided, implanted date: device was not implanted, explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.
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Event Description
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The user facility reported that after multiple catheter exchanges, the glidesheath slender sheath shaft telescoped into the hub of the sheath and protruded out the valve causing bleeding.The sheath was exchanged for a 6f pinnacle due to 0.035" wire that was already in the body.The sheath was in the right radial artery during the percutaneous coronary intervention.The estimated blood loss was less than 250cc.There was no patient injury/medical or surgical intervention required.The patient was in stable condition and the procedure outcome was successful.
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Manufacturer Narrative
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This report is being submitted as follow up no.1 to provide a correction to the sample receipt date in section d9, to update section h3, and to provide the completed investigation results.One 6fr glidesheath slender was returned for product evaluation.No other components were received for product evaluation.Visual inspection revealed that the sheath had a major kink at 2.8 cm from the hub.Dimensional testing was performed.The inner diameter of the sheath was measured to be 2.07 mm which was within the manufacturer's specification of 2.02-2.13mm.Based on the returned device, the complaint can be confirmed for the sheath/catheter mechanical damage.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing, design or quality system issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the fmea.
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Search Alerts/Recalls
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