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When pulling the snare with the glide wire during through and through technique over the aortic bifurcation, curve in the indwelling catheter broke.However it remained attached to the body of the catheter.While pulling the catheter and removing it from the delivery system it remained intact without issue.After it was removed when they had a close look, there was a tear in the curve.
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1 x preloaded catheter from a zbis-12-45-41-ci (lot ac1077542) was returned for evaluation.The catheter appeared used with biological contaminants noted on the product.There was a longitudinal fracture in the tip of the catheter starting at approx.2.5cm form the base of the tip.No images were supplied for review.The work order and relevant manufacturing documentation were reviewed and appear complete and correct, with no evidence to indicate that the device and the catheter were not manufactured as per specification.Review of specifications found that there are a number of processes and checks to ensure that the catheter is not damaged prior to shipment.Review of ifu: the instructions for use (ifu) supplied with the device state: section 9.2 'inspection prior to use' states: inspect the device and packaging to verify that no damage has occurred as a result of shipping.Do not use this device if damage has occurred or if the sterilization barrier has been damaged or broken.If damage has occurred, do not use the product and return to cook.Prior to use, verify correct devices (quantity and size) have been supplied for the patient by matching the device to the order prescribed by the physician for that particular patient.Section 10.1 'zenith branch endovascular graft-iliac bifurcation preparation/flush' 10.1.3.Remove the pre-loaded wire guide from the delivery system.10.1.5.Insert a suitable hydrophilic nitinol core wire guide, 0.018 inch (0.46 mm) or 0.035 inch (0.89 mm) compatible and 260 cm in length, into the pre-loaded catheter.Section 10.3 'zenith branch endovascular graft-iliac bifurcation placement' 10.3.5.Insert zenith branch endovascular graft-iliac bifurcation delivery system over the wire guide, into the iliac artery until the tip of the in dwelling catheter, sitting in the groove in the dilator tip beneath the outer sheath, is just above the aortic bifurcation and in rotational alignment with the opposite common iliac artery origin.(figure 8) note: slight advancement of the hydrophilic wire guide through the tip of the catheter may aid in visualization of the catheter tip position.Section 10.4 'through-and-through wire guide placement' 10.4.1.Advance the hydrophilic wire guide and catheter into the aorta.Position the wire guide for snaring by advancing it through the tip of the curved catheter as required.10.4.2.Advance a suitable snare through the access sheath in the opposite iliac artery, snare the tip of the hydrophilic wire guide, and pull it through to form a through-and-through wire guide.(figure 9) caution: during this manoeuvre, the hydrophilic through-and-through wire guide should be advanced so that some slack is maintained at the aortic bifurcation.Section 10.6 '10.6 up-and-over sheath placement' 10.6.2.Advance a suitably sized up-and-over sheath over the hydrophilic nitinol core through-and-through wire guide until the tip of the sheath¿s dilator tip comes in contact with the tip of the pre-loaded catheter.(figure 13).Note: it may be necessary to apply gentle traction on both ends of the wire guide to aid in advancement.10.6.3.Clamp the hydrophilic through-and-through wire guide at both ends (where it emerges from the pre-loaded catheter and the up-and-over sheath).10.6.4.Continue to advance the sheath over the secured wire guide while applying gentle, intermittent tension on the pre-loaded catheter so that the sheath and catheter will advance over the bifurcation, into the proximal opening of the device, and out through the sidebranch.(figure 14) note: dependent upon the length of the dilator tip of this sheath, it may be necessary to advance the sheath over its dilator tip, to ensure sheath placement within the sidebranch.10.6.5.Remove the dilator of the up-and-over sheath.10.8 balloon-expandable covered peripheral bridging stent placement 3.Withdraw the hydrophilic nitinol core through-and-through wire guide and the pre-loaded catheter.A health risk assessment (hra) has been initiated to assess the impact of these catheters in the field.The hra concludes: "as the calculated rpn is still well below the rpn threshold, the benefit-risk ratio of this device remains favourable as per the design risk management process.Based on the clinical mitigations possible, the probability that the occurrence will result in serious injury or death is lower than the probability of occurrence itself.Analysis showed that none of the reported events resulted in serious injury or death to patients.The devices allow for patency to the iliac arteries to be maintained after aneurysm exclusion and therefore prevent bowel and buttock ischemia and claudication in these patients.In considering this, the benefit of being able to maintain patency to the internal iliac artery outweighs the unlikely occurrence of lower limb ischemia.Hence, the information presented in the hra supports that no action be taken to limit supply of hnbr4.1-35-85-p-ns-radt-bns catheters.Any corrective action or updates to risk management documents shall be processed under capa pr328789.The mandatory requirement to always review the complaint history during a complaint investigation, will ensure that trends are constantly monitored.From the information received and evaluation of the returned catheter, a definitive root cause was not able to be determined.It is most likely that the event was related to material failure of the catheter tip.
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