It was reported that on (b)(6) 2018 during a medical procedure, the patient was slowly decompensating, with right heart failure while on echo.An impella rp was placed for support for cardiomyopathy.Access to rfv; some difficulty placing swan initially into lpa branch.Rp advanced over wire, but would not make turn into pa, despite rotations with push-pull technique.An amplatz 0.035 wire placed as buddy wire, still not successful in turning into pa.Attempted to advance for at least 35 minutes.Had issues with bleeding from the peel-away sheath valve; patient required administration of two units of blood, d/t pressures dropping, gtts (drips) increased.Decision made to exchange sheath for another rp peel-away sheath.Rp re-advanced through new sheath but still would not make turn.After another 20 minutes the second peel-away began to exhibit bleeding back through the valve, so decision made to abort rp and place patient on tandem heart via right ij.Bleeding was resolved by removing sheath, suture placed and manual pressure held.Patient was reported to be critical, tandem heart placed and patient was successfully supported with the tandem heart.
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Two 23f abiomed introducer sheaths from lot c1-12603 were returned from the customer without the dilators.There were no other accessories.The device history record was reviewed to confirm that the device passed all applicable in process and final inspections.Blood was found on and inside both sheaths.Both sheaths were kinked and both sheaths had torn hemostasis valves.Upon evaluation of the returned devices under a 10x microscope, it was found that the 1st sheath was kinked at approximately 16cm from the distal tip and the hemostasis valve was torn.The 2nd sheath was kinked at approximately 17.5cm from the distal tip and the hemostasis valve was torn.It was found that the insertion points into the hemostasis valves were identified to be considerably off center of the cross cuts, creating a tear in both valves.Returned device analysis reveals two 23f abiomed introducer sheaths that are within manufacturing specifications.According to the complaint report, the patient experienced bleeding from the sheath.Both sheaths were found to have a torn hemostasis valve which would account for the blood loss from the sheaths.The valves were torn as a result of off center insertion due to use error/mishandling in the field.The introducer sheaths passed all in-process and qa final inspection steps before shipping to the customer including visual, dimensional and leak testing.Per qa procedure, abiomed introducer sheath in-process and final inspections: perform pressure and vacuum leak test per procedure, latest revision.This procedure is performed by qa 100%.As per instructions for use: when assembling the sheath and dilator, care must be taken to insert the dilator tip straight through the center of the valve membrane in order to prevent inadvertent puncturing of the membrane.Capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.In addition, there was no new failure mode identified and the risk remains acceptable.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.Oscor inc.Is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report is based upon information obtained by oscor inc.Which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, oscor inc., or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, oscor inc., or its employees, that the report constitutes an admission that the device, oscor inc., or its employees caused or contributed to the event described in this report.
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