During maneuvering of the guidestar to achieve the ripv, the pull wire broke (curve mechanism of the handle) and the sheath only had a small deflection.The physician attempted to reach the vein using the heliostar catheter deflection but with no success.The procedure was finished when both catheter and sheath were removed, it was reported there was a 20 minute delay in procedure.No patient consequences reported.No additional information.
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The following sections were updated in follow-up 1: b4, d9, g3, g6, h2, h3, h6, and h10: the device was used in treatment.One 13.5f guidestar steerable introducer sheath was received without the dilator.There were no other accessories.Traces of blood were found on and inside the sheath.According to the event description summary, the sheath would deflect only slightly.Upon evaluation of the returned product, it was found that the sheath would deflect slightly, then after a few more rotations of the deflection collar it would not deflect at all.The sheath was x-rayed through distal tip.It was found that the anchor ring remained in its original intended position and the pullwire was still attached without any damage.When the handle was x-rayed, it was found that the small and large hypotubes were intact and there was no slack in the pullwire coming out of the large hypotube.When the handle was removed, it was found that the crimps that hold the assembly together were insufficient.When the smaller hypotube was pulled with a slight amount of force, the hypotube/pullwire assembly fell apart.Returned device analysis revealed sheath would no longer deflect.The crimp in the hypotube that holds the pullwire in place was not sufficient enough to hold the entire assembly together.The manufacturing and qa procedures were updated to add dual crimper and controls to avoid future complaints.This complaint lot was manufactured prior to this procedure change.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections before shipping to the customer.Per manufacturing procedure (destino twist steerable guiding sheath handle assembly) sample size: 100% · position the small hypo-tube onto the pull wire of the sheath.Insert the small hypo-tube into the large hypo tube until it is bottomed out inside the large hypo-tube.Using a ruler, measure the exposed length of the small hypo-tube.Pull the small hypotube an additional 4+/-0.5mm out of the large hypo-tube.Verify that the exposed length of the small hypo-tube is 4+/-0.5mm longer than the bottomed out measurement.· verify that there are two crimps present and using a ruler verify that the distance between the crimp 1 and the proximal end is 3+/-0.5mm and the second crimp is 8+/-0.5mm from the proximal end.Trim the excess pull wire that extends past the small hypotube.The instructions for use (ifu) in forms the user: preparing steerable sheath for insertion: · verify deflecting and straightening of the distal section of the steerable sheath using the handle of the sheath.Refer to deflecting and straightening the steerable sheath" for instructions.General use of the steerable sheath: · do not force the steerable sheath assembly if significant resistance is encountered during the insertion or passage.If resistance is encountered, determine the cause and correct before continuing the procedure.Deflecting and straightening the steerable sheath: · twist the deflection collar slowly and carefully to deflect the distal tip.Caution: the sheath will deflect at the speed which the deflection collar is turned.Avoid rapid deflection that may cause vessel damage.· when the desired deflection point or site access is achieved, stop turning the deflection collar.No further follow-up is required.Manufacturing and qa procedures were updated to ensure the crimp on the hypo tube assembly holds together.This lot was manufactured prior to the procedures updated.In addition, there was no new failure mode identified and the risk remains low and is 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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