Model Number IPN008881 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Cardiac Arrest (1762); Hematoma (1884); Hemorrhage/Bleeding (1888)
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Event Date 10/23/2021 |
Event Type
Injury
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Manufacturer Narrative
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Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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7 ligaclips falling off the saphenous vein, 2 from side branch on a grafted coronary artery, 5 from the lighted end of the saphenous vein in the donau leg.Ligation clip applicator identified and tested and removed from circulation after concerns identified.Clinical incident raised and serious investigation process commenced at hospital.Clinical consequences: pea cardiac arrest with emergency resternotomy on itu and arrest of bleeding from bleeding side branch of saphenous vein graft to coronary artery.Hematoma of donor leg site.
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Manufacturer Narrative
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(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet, inc.Kenosha wi facility as part of a 50-piece lot in october of 2017.Evaluation of the returned instrument shows that the tips are slightly misaligned in the closed position.Although the tips are slightly misaligned in the closed position functional testing shows that this instrument is able to pick-up , retain, close and release multiple clips.8 closed clips where measured as they were at time of production and all 8 clips measured to hemoclip plus applier specifications of.0078" max.Leg gap at (.0041"-.0049") and.0061" max.Eye gap at (.0019"-.0035") we are unable to determine what caused the tips to be slightly misaligned but mishandling at the end user's facility is suspected.We are also unable to determine what caused the alleged defect at the end user's facility since all the leg and eye gaps of the clips closed during our testing measured within factory specifications.
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Event Description
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7 ligaclips falling off the saphenous vein, 2 from side branch on a grafted coronary artery, 5 from the lighted end of the saphenous vein in the donau leg.Ligation clip applicator identified and tested and removed from circulation after concerns identified.Clinical incident raised and serious investigation process commenced at hospital.Clinical consequences: pea cardiac arrest with emergency resternotomy on itu and arrest of bleeding from bleeding side branch of saphenous vein graft to coronary artery.Haematoma of donor leg site.
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Search Alerts/Recalls
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