| Catalog Number 425-2022X |
| Device Problems
Difficult to Insert (1316); Kinked (1339); Material Separation (1562); Sticking (1597); Physical Resistance (2578)
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| Patient Problem
Foreign Body In Patient (2687)
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| Event Date 11/22/2016 |
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Event Type
Injury
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Manufacturer Narrative
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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 the device is pending.The investigation is currently in progress.Not returned.
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Event Description
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It was reported that the device separated while inside the patient.There were no anomalies noted during the prep of the device.There was no damage noted to the box, pouch, hoop or balloon sleeve.There were no kinks noted on the device prior to use.The target lesion was the left superficial femoral artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was 100 % (cto).A contralateral approach was made from the right common femoral artery.A destination, terumo introducer sheath was inserted and a tempo uf angio catheter was delivered near the left femoral artery.It attempted to cross the cto lesion antegradely, but the origin of the superficial femoral artery was blocked and obscure.Therefore a side puncture was made near the origin of the anterior tibial artery.A guide wire advanced retrogradely to the lesion.The guidewire crossed the lesion with other guidewires and a prominent, tokai medical micro catheter.This guide wire and the sheath introducer from the right femoral artery merged to perform wire rendez-vous.The micro catheter was inserted into the sheath introducer, and the guide wire was changed to a 0.014*300cm wire.) it advanced from the right common femoral artery to the right anterior tibial artery.The complaint device was then advanced to the lesion inflating with some resistance.While advancing the device the balloon became stuck and the physician decided to remove the balloon.When withdrawing the device the resistance disappeared and the balloon separated inside the patient.The visible part of the intracorporal balloon was only its balloon marker, which indicated that the balloon lay over the left common iliac artery to the middle portion of the left femoral artery.The separated part of the balloon was not confirmed on the angiography.Also the sheath introducer moved while the balloon was advancing, and the tip of the sheath introducer was confirmed to be in the end of the right common iliac artery.A snare wire (gooseneck) was inserted to retrieve the separated balloon, but it could not advance smoothly and failed.When the sheath introducer moved, the balloon marker moved as well, so the sheath introducer was slowly retracted and it was removed all together with the separated balloon.The balloon was observed and the separated part seemed to be pricked in the inner lumen of the sheath introducer.All parts of the device were removed from the patient.The sheath introducer was replaced with a new product because the inner lumen looked damaged.With the micro catheter and the guide wire, the procedure proceeded.A 2*220 coyote, boston scientific balloon catheter inflated in the lesion, and ivus observation was done.Kta was performed with two balloon catheters (5*15 sterling, boston scientific) (rapidstream, nipro) in the junction of the right superficial femoral artery and the right deep femoral artery.The same balloon (5*15 sterling, boston scientific) inflated in the superficial femoral artery again.From the distal portion, two smart stents (7*150) and one smart stent (8*100) were deployed, and post-dilation was performed by the balloon (5*15 sterling, boston scientific).The hemostasis at the ata puncture site was achieved by a balloon.A dissociative lesion was confirmed in the right external iliac artery, and a smart stent (10*40) was deployed.The hemostasis was achieved by an exoseal.The procedure finished successfully.The product was clinically used.And it will be not returned for analysis.It was reported that the possible cause of the separation was that the rx port of the sleek went far forward and came out from the sheath introducer in the terminal aorta, and it got kinked upwards.Then it was pulled back into the sheath introducer, and its hypo tube was stretched and stuck in the inner lumen of the sheath introducer which led to balloon separation.Reportedly the patient did not experience any complications as a result of the failure with the device.
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Manufacturer Narrative
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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 separated while inside the patient.There were no anomalies noted during the prep of the device.There was no damage noted to the box, pouch, hoop or balloon sleeve.There were no kinks noted on the device prior to use.The target lesion was the left superficial femoral artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was 100 % (cto).A contralateral approach was made from the right common femoral artery.A destination, terumo introducer sheath was inserted and a tempo uf angio catheter was delivered near the left femoral artery.An attempt was made to cross the cto lesion antegradely, however the origin of the superficial femoral artery was blocked and obscure.Therefore a side puncture was made near the origin of the anterior tibial artery.A guide wire was advanced retrogradely to the lesion.The guidewire crossed the lesion with other guidewires and a prominent, tokai medical micro catheter.This guide wire and the introducer sheath from the right femoral artery merged to perform wire rendez-vous.The micro catheter was inserted into the introducer sheath and the guide wire was changed to a 0.014, 300 cm wire.The wire advanced from the right common femoral artery to the right anterior tibial artery.The complaint device was then advanced to the lesion with some resistance.While advancing the device the balloon became stuck and the physician decided to remove the balloon.However, when withdrawing the device the resistance disappeared and the balloon separated inside the patient.The visible part of the balloon was only its balloon marker, which indicated that the balloon lay over the left common iliac artery to the middle portion of the left femoral artery.The separated part of the balloon was not confirmed on the angiography.Also the introducer sheath moved while the balloon was advancing and the tip of the introducer sheath was confirmed to be in the end of the right common iliac artery.A gooseneck snare wire was inserted to retrieve the separated balloon, but it could not advance smoothly and failed.When the introducer sheath moved, the balloon marker moved also.The introducer sheath was slowly retracted and it was removed all together with the separated balloon.The balloon was observed and the separated part seemed to be pricked in the inner lumen of the introducer sheath.All parts of the device were removed from the patient.The introducer sheath was replaced with a new product because the inner lumen looked damaged.With the micro catheter and the guide wire, the procedure proceeded.The procedure was completed successfully using other devices.It was reported that the possible cause of the separation of the complaint device was that the rx port of the device went far forward and came out from the introducer sheath in the terminal aorta and became kinked upwards.Then it was pulled back into the introducer sheath, and its hypo tube was stretched and stuck in the inner lumen of the introducer sheath which led to balloon separation.Reportedly the patient did not experience any complications as a result of the failure with the device.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.The returned sample was in poor condition and in two pieces.No external or internal packing was returned.The hub was printed as expected and no visual defects were observed.The hypotube was returned in two pieces.A total of two kinks and eight bends were noted between the two separate pieces.The device was separated in two pieces.The break is quite jagged and is not circular in shape.The first section (hub side) was approx.1100 mm in length.There was a torn/jagged edge.A total of three minor bends were noted on the device.The first bend was noted approx.380 mm from the strain relief, the second was noted approx.715 mm from the strain relief and the third bend was noted approx.820 mm from the strain relief.The second section (balloon side) was approx.450 mm in length.There was a torn/jagged edge.A total of five minor bends were noted on the device.Two kinks were also noted on the device.The first kink was noted approx.70 mm from the break point in the hypotube and the second severe kink was noted in the balloon approx.35 mm from the proximal bond.No visual defects were noted on the transition outer.Evidence of a tear was noted in the re-port.The total length of the tear is approx.2 mm.The balloon arrived back with evidence of brown fluid in the balloon.There was also dried red substance in the balloon.The distal tip is positioned within the balloon.A 0.014 guidewire was inserted into the device through the re-port without any issues.The device was inflated to 6 atm and the balloon held pressure for approx.2 minutes.It deflated without any issues.The evaluation of the complaint device has confirmed the reported failure mode.Based upon the available information a definitive root cause cannot be determined.The surgical procedure was very challenging and complicated.The rate of stenosis was 100%.It is therefore likely that handling or procedural techniques may have been contributory factors in causing the event.Based on analysis performed no additional action is required at this time.However the complaint rate for this failure mode is 0.04%.This is above the predicted of 0.01%.Therefore an event has been raised in our quality system to address this issue.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 304 v 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.(b)(4).
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Event Description
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It was reported that the device separated while inside the patient.There were no anomalies noted during the prep of the device.There was no damage noted to the box, pouch, hoop or balloon sleeve.There were no kinks noted on the device prior to use.The target lesion was the left superficial femoral artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was 100 % (cto).A contralateral approach was made from the right common femoral artery.A destination, terumo introducer sheath was inserted and a tempo uf angio catheter was delivered near the left femoral artery.An attempt was made to cross the cto lesion antegradely, however the origin of the superficial femoral artery was blocked and obscure.Therefore a side puncture was made near the origin of the anterior tibial artery.A guide wire was advanced retrogradely to the lesion.The guidewire crossed the lesion with other guidewires and a prominent, tokai medical micro catheter.This guide wire and the introducer sheath from the right femoral artery merged to perform wire rendez-vous.The micro catheter was inserted into the introducer sheath and the guide wire was changed to a 0.014, 300 cm wire.The wire advanced from the right common femoral artery to the right anterior tibial artery.The complaint device was then advanced to the lesion with some resistance.While advancing the device the balloon became stuck and the physician decided to remove the balloon.However, when withdrawing the device the resistance disappeared and the balloon separated inside the patient.The visible part of the balloon was only its balloon marker, which indicated that the balloon lay over the left common iliac artery to the middle portion of the left femoral artery.The separated part of the balloon was not confirmed on the angiography.Also the introducer sheath moved while the balloon was advancing and the tip of the introducer sheath was confirmed to be in the end of the right common iliac artery.A gooseneck snare wire was inserted to retrieve the separated balloon, but it could not advance smoothly and failed.When the introducer sheath moved, the balloon marker moved also.The introducer sheath was slowly retracted and it was removed all together with the separated balloon.The balloon was observed and the separated part seemed to be pricked in the inner lumen of the introducer sheath.All parts of the device were removed from the patient.The introducer sheath was replaced with a new product because the inner lumen looked damaged.With the micro catheter and the guide wire, the procedure proceeded.The procedure was completed successfully using other devices.It was reported that the possible cause of the separation of the complaint device was that the rx port of the device went far forward and came out from the introducer sheath in the terminal aorta and became kinked upwards.Then it was pulled back into the introducer sheath, and its hypo tube was stretched and stuck in the inner lumen of the introducer sheath which led to balloon separation.Reportedly the patient did not experience any complications as a result of the failure with the device.
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Search Alerts/Recalls
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