|
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: "[warnings] ¿ method for use 1.If any abnormalities occur during use of the stent, immediately stop use and take appropriate steps.It could lead to serious health hazard.2.Do not forcibly insert or remove the stent.It may injure patient or/and damage this product.3.When using the multi-length type stent, it should be avoided in the following cases.A) if you measure the length of patient¿s ureter and confirm that excessive coil part would be appear , consider using other stent which has different shape of tip and length.Ureteral stents with excessive coil parts have risks of knot formation at the tip of renal pelvis side during placement or removal.1) b) if any resistance is felt during removal, confirm the cause of the resistance with fluoroscopy and take remedial action to solve the problem.Excessive force during removal may lead to damage of the renal pelvis and/or ureter.4.Ureteroarterial fistula may be formed between the ureter and the aorta or the iliac artery and result in massive hemorrhage at the replacement of the ureteral stent if a ureteral stent is placed for a long term in a patient who has undergone the intrapelvic surgery or irradiation.Therefore, carefully monitor the condition of the patient, and in the event of acknowledging bleeding from the urethra, perform retrograde pyelography or angiography, and provide appropriate care. 1.Do not manipulate, advance and/or withdraw the guidewire through a metal cannula or needle; to do so may result in damage the guidewire.2.Do not advance or withdraw a guidewire when resistance is encountered as perforation could occur.3.Do not use a retrieval device while the guidewire is in place; to do so may cause damage to the guidewire.4.Sufficient guidewire length must remain exposed to maintain a firm grip on guidewire at all times.5.Inspect guidewire for damage prior to use.Do not attempt to use the guidewire if it has been damaged.Use of a damaged wire may result in damage to the urinary tract.6.Do not reshape the guidewire by any means.Attempting to reshape the wire may cause damage resulting in release of wire fragments into the urinary tract.Failure to exercise proper cautions may result in damage to the urinaly tract.7.Attention should be paid to guidewire movement in the urinary tract.Before a guidewire is moved or torqued, tip movement should be examined under direct vision or fluoroscopy.8.Do not wipe guidewire with alcohol, organic medical solutions or chlorhexidine gluconate aqueous solutions since they will damage the device.9.Do not use organic medical solutions or oily contrast medium on this device since they will damage the device.10.Avoid contact with devices with sharp edges (such as metal dilator) as this may cause damage the guidewire.11.Avoid use of the device when resistance is encountered (due to the size of a catheter, stent and/or working-channel of endscope) as this may cause wear the guidewire coating.< ureteral catheter> 1.Ureteral catheter should not be used as a ureteral splint.[contraindications and prohibitions] ¿ method for use 1.This products are single use only.Do not resterilize.[configuration / structure / principle, etc.] bard® inlay® stent set comprises the following components.1.Bard® inlay® ureteral stent the bard® inlay® ureteral stent is a double pigtail ureteral stent with monofilament suture loop attached to aid in stent removal.The stent is available in two forms: a single size or a customized multi-length size. * stent diameter: 1.6mm(4.7fr), 2.0mm(6fr), 2.3mm(7fr), 2.7mm(8fr) * stent length: double j type: 14cm, 20cm, 22cm, 24cm, 26cm, 28cm multi-length type: 22cm ¿ 32cm ¿the length of ureteral stents of c.R.Bard, inc.Is illustrated as follows: 2.Tigertailtm ureteral catheter bard® inlay® stent set comes in two types: with ureteral catheter and without ureteral catheter. polyurethane 3.Guidewire bard® inlay® stent set comes in several types: with guidwire (bard® hydroglide® guidewire or vanbute-glide guidewire lz) or without guidewire.[intended use & effect- efficacy] bard® inlay® stent set is indicated to relieve obstruction in a urinary tract and to be used for urethral catheterization from renal pelvis to urinary bladder.Each disposable kit contains several packaged medical devices that are necessary for stent placement in ureter.[directions for use] determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram.Accurate measurements will optimize drainage efficiency and patient comfort.1.Insertion of the guidewire 1) remove the guidewire from the packaging together with the guidewire holder.Prior to removing the guidewire from the guidewire holder, inject sterile water through the port to activate the lubricious coating.2) remove the guidewire from the guidewire holder and carefully inspect for bends, kinks, or a damaged tip.3) introduce the guidewire, flexible end first, into the working channel of a cystoscope into the urinary tract.Note: activate the guidewire coating according to the ¿instructions for use¿ found within the guidewire packaging.4) advance the guidewire slowly into the desired position until the tip is in the renal pelvis.Continuously confirm guidewire position either visually or under fluoroscopy.2.Nephroureterography 1) place the tigertailtm ureteral catheter over the guidewire and insert it into the ureter.Note: in this case, it is also possible insert the ureteral catheter without using a guidewire, at the discretion of a physician.2) removing the guidewire.3) the ureteral catheter adapter is secured to the terminal end of the ureteral catheter, and the urine drainage or retrograde phelography is performed using syringe.4) introduce the guidewire again for stent placement and remove the ureteral catheter from the cystoscope.3.Stent placement 1) in order to improve sliding, immerse the stent in a normal saline solution.2) confirm the guidewire position where it coils inside the renal pelvis.3) move the pigtail straightener over the proximal end (kindney coil end without the suture) of the ureteral stent, allowing easier insertion onto the guidewire.4) remove the pigtail straightener once the stent is secure on the guidewire.5) pass the stent over the guidewire through the cystoscope by using the push catheter with radiopaque tip for proper placement.6) watch the distal end (bladder coil end with the suture) of the stent or radiopaque, proximal end of the push catheter.Stop advancing when the stent¿s distal end is watched.Multi-length ureteral stent to accurately size this stent count the marker bands as it is being advanced into the ureter.The first (wide) marker band on this device indicates 22 cm, followed by two narrow bands at 24 cm and 26 cm.The last (wide) one indicates 28 cm.If you need to place the 30 cm or 32 cm lengths, use the attached suture or endoscopic forceps to gently pull back on the stent, unwinding the coil from the kidney.7) confirm proximal end of the pusher and stent¿s distal end marker (bladder end), reaches the ureterovesical junction (uvj) by fluoroscopy.8) holding the stent in position with the pusher, cut the suture and pull it out slowly.Note: the suture may be removed prior to placement or may be removed once indwelling by using an appropriate cystoscopic instrument.9) withdraw the guidewire slowly.The stent will form a pigtail automatically 10) carefully remove the push catheter.11) confirm position of placing the stent by fluoroscopy.[precautions] 1.Important basic precautions ¿ please read all instructions prior to use and follow them.¿ this product is a medical device for qualified physicians, and should not be used for any other purpose.¿ only physicians qualified in the appropriate surgical techniques should use and administer this product.¿ this product is a disposable, supplied sterile.If package is opened or expiration date has passed, do not use.Do not resterilize.¿ confirm that all the contents enclosed in the package.¿ use this product under strict aseptic procedures.¿ follow the ifu of licensed marketing approval holder for any other medical equipment and/or medication to be used in conjunction with this device.2.Method for use a) stent ¿ care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation.¿ improper handling technique can seriously weaken the stent.Acute bending or overstressing during placement could result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.¿ exercise care.Tearing of the stent can be caused by sharp instruments.¿ suture may be cut off prior to stent placement.Remove suture prior to placement for pediatric patients.¿ with any ureteral stent, migration is a possible complication which could require medical intervention for removal.Selection of too short a stent may result in migration.¿ ureteral stents should be checked periodically for signs of encrustation and proper function.Periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician in consideration of the individual patient¿s condition and other patient specific factors.The stent is not intended as a permanent indwelling device.¿ after placing procedure, confirm position of stent by fluoroscopy.B) guidewire ¿ inject sterile water into the guidewire holder in order to wet the guidewire.Do not insert a stent over the device with its surface insufficiently wet.The guidewire is treated with a hydrophilic coating.¿ never use dry gauze.Dry gauze will damage the surface of the hydrophilic guidewire and increase resistance when trying to insert catheter, stent or endoscope.C) ureteral catheter ¿ when using the tiger tail ureteral catheter, especially without the stabilizing support of a guidewire, be aware that a malfunction may occur where the flexible tip may detach if excessive force is made in contact with the walls of the bladder, ureter or renal pelvis.Should the flexible tip portion of the catheter become detached, retrieve with an endourology grasping device.¿ do not withdraw the ureteral catheter while it is deflected in endoscope.Avoid sharp bending.¿ when performing drainage of urine, restrograde visualizations etc.Though the ureteral catheter, attach the ureteral catheter adapter to the tip of ureteral catheter.¿ do not over-tighten the catheter adapter.Over-tightening of the catheter adapter may occlude the lumen of the catheter.3.Mulfunction and adverse events potential complication associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: 1) significant malfunction ¿ stent dislodgement, fragmentation, migration, occlusion ¿ stent encrustation ¿ stent knotting 1) ¿ guidewire kinking, fragmentation 2) adverse events ¿ edema ¿ loss of renal function ¿ extravasation ¿ pain/discomfort ¿ fistula formation ¿ perforation of kidney, renal pelvis, ureter and/or bladder ¿ hemorrhage ¿ peritonitis ¿ hydronephrosis ¿ infection ¿ stone formation ¿ ureteral erosion ¿ ureteral reflux ¿ urinary symptom 4.Precautions for infection or contamination ¿ this device is supplied sterile.Inspect the packaging to be sure it is intact and undamaged prior to use.If the packaging has been opened or if the expiration date has passed, do not use the product.Do not resterilize.¿ after use, this product may be a potential biohazard.Handle and dispose of it in accordance with local regulations.[storage and expiration date] 1.Storage method keep product dry and clean, away from direct sunlight and humidity, and avoid sterilization lamps and other ultraviolet light.2.Duration of use it is recommended that the indwelling time not exceed 365 days.(note the indwelling time vary in patients or their urino-condition.) close observation of the patient should be made by doctor.3.Expiration date please see the expiration date indicated on the product label.[packaging] one unit per box" (b)(4).
|
