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The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Receipt of device is pending.The investigation is currently in progress.
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It was reported that the device failed to advance and then separated.The target lesion was the right anterior tibial artery.The rate of stenosis was 100 % (cto).An ipsilateral approach was made with a 4.5f 50cm parent, medikit introducer sheath to the popliteal artery.A cruise, st.Jude medical guidewire and a prominent neo, tokai medical micro catheter were advanced to the anterior tibial artery.The guide wire was exchanged to a chevalier universal 300, fmd guidewire.The complaint device was inserted into the patient.However the device failed to advance further than the middle portion of the anterior tibial artery.After several times of attempts, the shaft of the device became separated at a part which was not covered with the introducer sheath.The device was removed from the patient.A 2mm*22cm coyote, boston scientific device was used to complete the procedure successfully.There was no patient injury reported.
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The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.It was reported that the device failed to advance and then separated.The target lesion was the right anterior tibial artery.The rate of stenosis was 100 % (cto).An ipsilateral approach was made with a 4.5f 50cm parent, medikit introducer sheath to the popliteal artery.A cruise, st.Jude medical guidewire and a prominent neo, tokai medical micro catheter were advanced to the anterior tibial artery.The guide wire was exchanged to a chevalier universal 300, fmd guidewire.The complaint device was inserted into the patient.However the device failed to advance further than the middle portion of the anterior tibial artery.After several times of attempts, the shaft of the device became separated at a part which was not covered with the introducer sheath.The device was removed from the patient.A 2mm*22cm coyote, boston scientific device was used to complete the procedure successfully.There was no patient injury reported.The lot history records have been reviewed with special attention to the manufacturing and inspection of this product.The device was found to have met specifications prior to shipment.No manufacturing anomalies were identified that may have caused or contributed to the reported event.This is the first event reported for this lot number and issue to date.The device was returned for evaluation.No external or internal packing was returned.The device was returned in two pieces.The hub was printed as expected and no visual defects were observed.The device was visually inspected under 4x-60x magnification by digital microscope camera.The hypotube was returned in two pieces.A total of 2 kinks and 4 bends were noted between the two separate pieces.One kink was noted on the first piece of the device.The kink was noted approx.75mm from the first markerband (kink was positioned between 1st & 2nd markerband).Three bends were noted on the first piece of the device.The first bend was noted approx.135mm from the hub and the second bend was noted approx.434mm from the hub.The break on this piece is quite jagged and is not circular in shape.The device separated approx.23mm from the second markerband.One severe kink was noted approx.79mm from distal tip on the second piece of the device.Two bends were noted on the second piece of the device.The first bend was noted approx.13mm from the separated end and the second severe bend was noted approx.41mm on the transition outer.The break on this piece is also quite jagged and not circular in shape.There was one kink noted on the transition outer.There were four bends noted on the outer.There was one severe kink was noted on the inner.Severe bunching was noted on the inner, just at the proximal markerband.Severe bunching of the balloon was noted at the proximal markerband.No visual defects were observed on the re-port or distal tip.No functional examination carried out on the device as not applicable to the complaint.The result of the investigation is confirmed.Based upon the available information and investigation carried out a definitive root cause cannot be determined.It is unknown whether patient factors such as the stenosis rate of 100%, handling or procedural techniques or the have contributed to the reported event.Based on analysis performed no additional action is required at this time.The ifu states: description: ¿ the sleek® percutaneous transluminal angioplasty (pta) peripheral catheter family comprise a range of sizes of rapid exchange catheters for peripheral angioplasty.The catheter¿s proximal tubing is 304v stainless steel and the distal coaxial tubings are nylon co-polymer blend.The lumen of the shaft is used for the purpose of inflating and deflating the balloon.A second lumen at the tip is used for advancing the guidewire.Indications: the sleek® catheters are intended for balloon dilatation of the femoral, popliteal and infra-popliteal arteries.These catheters are not designed to be used in the coronary arteries.Warnings: ¿ reuse, resterilization, reprocessing and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Precautions: ¿ carefully inspect the catheter prior to use to verify that the catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.¿ proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.¿ if the hypotube kinks prior to or during use the catheter should be discarded.No attempt should be made to straighten a kink in the hypotube.Storage: store in a cool, dark, dry place.Use the catheter prior to the ¿use by¿ date specified on the package.Directions for use: inspection and preparation ¿ remove the balloon sleeve by first withdrawing the shipping mandrel slightly and then slowly removing the sleeve while holding the catheter as close to the balloon as possible.¿ if any resistance is felt, or if any stretching of the catheter is observed while removing the balloon sleeve, the product should not be used.¿ the catheter should then be inspected for bends, kinks or stretched portions.Do not use if product damage is evident.Deflation and withdrawal ¿ simultaneously withdraw the dilatation catheter and guidewire from the guiding catheter/sheath.As the balloon exits the vessel, use a smooth, gentle, steady, motion.If resistance is felt upon removal then the balloon, guidewire and the guiding catheter/sheath should be removed together as a unit under fluoroscopic guidance, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and guiding catheter/sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction.
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