|
The reported event was confirmed ¿ cause unknown.Based on the evaluation, there was white plastic part comes out from inside the stent lumen.This will caused stent unable to insert through guidewire due to blockage lumen during used.It is unknown how the unknown plastic part present inside the stent lumen.Thus, the exact cause of how and when problem occurred could not be determined.A potential root cause for this failure could be due to user related or supplier (example: mishandling product/material brittle).The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "bard ® i n l ay o ptima tm stent set single use only.[warnings] 1.Method for use (1)when using the multi length type stent , it should be avoided in the following 1)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 stent s with excessive coil parts have risks of knot formation at the tip of renal pelvis side during placemen t or removal.2)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.(2)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.[contraindications] 1.Method for use (1) do not reuse.(2) do not resterilize 2.Applicable patients do not use for the woman who is pregnant or may become pregnant.[to avoid radiation exposure on pre born baby from x ray.] [shape, configuration and principles] bard® i n l ay o ptima tm stent set comprises the following components.1.B ard ® i n l ay o ptima tm ureteral stent the b ard ® i n l ay o ptima tm 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.There are two types of stent: those which have side holes and have without side hole polyurethane the length of ureteral stents of c.R.Bard, inc.Is illustrated as follows: 2.Pusher with radiopaque tip polyethylene 3.Tigertail tm ureteral catheter polyurethane 4.Piolax® hydrophilic guidewire lz (endo access®) [intended use & effect- efficacy] bard ® inlay optima tm 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] 1.Method of use determine the proper stent length for the patient.This is generally calculated from the ureteral catheter adapt or bard ® inlay optima tm stent (multi-length type) bard ® inlay optima tm stent stent (double j type) side hole pigtail straightener scale (5 cm) length of stent (shaft) baseline pyelogram.Accurate measurements will optimize drainage efficiency and patient comfort.(1) insertion of the guidewire 1) 1) remove the guidewire from the remove the guidewire from the packagingpackaging,, together with the guidewire holder.Together with the guidewire holder.2) 2) prior to removing the guidewire from the prior to removing the guidewire from the guidewire holderguidewire holder, inject sterile water , inject sterile water through the port to activate the through the port to activate the hydrophilic hydrophilic coatingcoating.3) remove the guidewire from the guidewire holder.Before using the guidewire, confirm the surface slides well when removing it from the holder.If you feel any resistance, do not force it, and inject the normal saline solution into the holder again, then try pulling it out once more.4) insert the guidewire either through the working channel of an endoscope or percutaneously, with the soft end of the guidewire first.5) advance the guidewire 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 ttigerigerttailailtmtm ureteral catheterureteral 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 performing the urine drainage or retrograde pyelography using with syringe.4) introduce the guintroduce the guidewiredewire again for stent placement and ragain 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 (kidney coil end without the without the suture)suture) of the ureteral stent, allowing easier insertion onto the guidewire.4) remove the pigtail straightener once the stent is secure on the guidewire and pass the stent over the guidewire through the cystoscope by using the pusher with with radiopaque tipradiopaque tip for proper placement.5) keep watching the distal end (bladder coil end with the suture) of the stent or radiopaque, proximal end of the pusher while advancdvancinging toto proproper position of per position of the the stentstent.Holdhold the guidewire the guidewire toto keep it from moving.Keep it from moving.6) 6) stop advancing when the stent¿s distal end stop advancing when the stent¿s distal end is identifiedis identified.If the if the proximal endproximal end is is inserted too much, pull the suture to modify the stent inserted too much, pull the suture to modify the stent properly.Properly.7) confirm 7) confirm proximal end of the pusherproximal end of the pusher and and stentstent¿¿s distal end marker s distal end marker (bladder end), (bladder end), reaches the ureterovesical junction (uvj)reaches the ureterovesical junction (uvj) by fluoroscopy.By fluoroscopy.8) holding the stent in position with the pusher, cut the suture and pull it out.9) withdraw the guidewire.The stent will form a pigtail automatically 10) carefully remove the pusher.11) confirm position of the stent by fluoroscopyfluoroscopy.< > to accurately size this stent to accurately size this stent,, count the marker bands as it is being advanced into the count the marker bands as it is being advanced into the ureter.Ureter.The first (wide) marker band on this device inthe first (wide) marker band on this device indicates 22 cm, followed by two dicates 22 cm, followed by two 4 narrow bands at 24 cm and 26 cm.The last (wide) one indicates 28 cm.Narrow bands at 24 cm and 26 cm.The last (wide) one indicates 28 cm.If you need to if you need to place the 30 cm or 32 cm lengths, use the attached suture or endoscopic forceps 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 thgently pull back on the stent, unwinding the coil from the kidney.E kidney.2 2.Precautions for useprecautions for use (1) (1) when using the when using the ttigerigerttailailtmtm ureteral cureteral catheteratheter, especially, especially without the stabilizing without the stabilizing support of a guidewire, be aware that a malfunction may occur where the flexible tip support of a guidewire, be aware that a malfunction may occur where the flexible tip may detach if excessive force ismay detach if excessive force is made in contact with the walls of the bladder, ureter made in contact with the walls of the bladder, ureter or renal pelvis.Should the flexible tip portion of the catheter become detached, or renal pelvis.Should the flexible tip portion of the catheter become detached, retrieve with an endourology grasping device.Retrieve with an endourology grasping device.(2) (2) do not withdraw the ureteral catheter while it is deflected in endoscdo not withdraw the ureteral catheter while it is deflected in endoscope.Ope.(3 (3)) avoid sharp bendingavoid sharp bending of the ureteral catheter.Of the ureteral catheter.(4 (4)) when performing drainage of urine, retrograde visualizations etc.Though the ureteral when performing drainage of urine, retrograde visualizations etc.Though the ureteral catheter, attach the ureteral catheter adapter to the tip of ureteral catheter.Catheter, attach the ureteral catheter adapter to the tip of ureteral catheter.(5 (5)) do not overdo not over--tighten the catighten the catheter adapter.Overtheter adapter.Over--tightening of the catheter adapter tightening of the catheter adapter may occlude the lumen of the catheter.May occlude the lumen of the catheter. (1) (1) do not forcibly insert or remove the stent.It may injure patient or/and damage this do not forcibly insert or remove the stent.It may injure patient or/and damage this product.Product.(2 (2)) avoid improper handling of stent such as bending, avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could kinking, tearing, etc.Misuse could damage the overall integrity of the stent.Damage the overall integrity of the stent.(3 (3)) avoid contact with sharp edges as this may cause damage to the stent.If grasping avoid contact with sharp edges as this may cause damage to the stent.If grasping device is used, the stent should be removed from ureter first.Tearing of the stent can device is used, the stent should be removed from ureter first.Tearing of the stent can be be caused by sharp instruments.Caused by sharp instruments.(4 (4)) determine the proper stent length for the patient.Selection of too short a stent may selection of too short a stent may result in migration.Result in migration.(5 (5)) in the event of stent migration, cystoscopy or ureteroscopy should be used to return in the event of stent migration, cystoscopy or ureteroscopy should be used to return the stent to the original pthe stent to the original position or remove from the patient body.Osition or remove from the patient body.(6 (6)) any any signssigns of infection in the location of the stent placement require removal of the of infection in the location of the stent placement require removal of the stent.Stent.After checking the condition of the patient, a new stent should be placed.After checking the condition of the patient, a new stent should be placed.(7 (7)) care should be exercised when removing tcare should be exercised when removing the stent to eliminate tearing or he stent to eliminate tearing or fragmentation.Fragmentation. (1) (1) do not forcibly insert or remove the guidewire.It may injure patient or/and damage do not forcibly insert or remove the guidewire.It may injure patient or/and damage the device.The device.(2 (2)) do not manipulate, advance and/or withdraw the guidewire through a metal cannula or needle; to do so may result in damage the guidewire.Avoid contact with devices avoid contact with devices with with sharp edges (sharp edges (such as such as metal metal dilatordilator).).(3 (3)) avoid using of the device when resistance is encountered (dueavoid using of the device when resistance is encountered (due to the size of a to the size of a catheter, stent and/or workingcatheter, stent and/or working--channel of endoscope) as thchannel of endoscope) as this may cause wear the is may cause wear the guidewire coating.Guidewire coating.(4 (4)) do not use organic medical solutions or oily contrast medium on this devicedo not use organic medical solutions or oily contrast medium on this device.These.These solutions may damage the device or decrease the lubricity of the device.Solutions may damage the device or decrease the lubricity of the device.(5 (5)) the guidewire is treated with a hydrophilic coating.Do not insert a stent over the device with its surface insufficiently wet.Never use dry gauze.[hydrophilic polymer never use dry gauze.[hydrophilic polymer coating can be damaged, increasing resistance when trying to insert coating can be damaged, increasing resistance when trying to insert cathetercatheter, stent , stent or endoscope.]or endoscope.] ( (66)) if unusual resistance is met durinif unusual resistance is met during manipulation of the guidewire, do not force to g manipulation of the guidewire, do not force to 5 remove it.Carefully withdraw the guidewire as a unit.Remove it.Carefully withdraw the guidewire as a unit.( (77)) do not use a retrieval device while the guidewire is in place; to do so may cause do not use a retrieval device while the guidewire is in place; to do so may cause damage to the guidewire.Damage to the guidewire.(8 (8)) don¿t rub the guidewire with the edgedon¿t rub the guidewire with the edge of the holder.This could flake the hydrophilic of the holder.This could flake the hydrophilic coating.Coating.(9 (9)) avoid kinking, bending or twisting repeatedly the guidewire at acute bent site.It may avoid kinking, bending or twisting repeatedly the guidewire at acute bent site.It may lead to damage the guidewire.Lead to damage the guidewire.(10 (10)) never try to shape the guidewire.This could damage and break the never try to shape the guidewire.This could damage and break the cable cable corecore of of the guidewire.The guidewire.(11 (11)) sufficient guidewire length must remain exposed to maintain a firm grip on the sufficient guidewire length must remain exposed to maintain a firm grip on the guidewire at all times.Guidewire at all times.[precautions] [precautions] 1.1.Important important precautionsprecautions (1) (1) the stent the stent is is not intended as a permanent indwelling device.It is recommended thanot intended as a permanent indwelling device.It is recommended that t the indwethe indwelling time not exceed 365 days.Lling time not exceed 365 days.Periodic checks of the stent by cystoscopic and/or radiographic procedures are periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician in recommended at intervals deemed to be appropriate by the physician in cconsideration of the individual patient¿s condition and other ponsideration of the individual patient¿s condition and other patient specific factorsatient specific factors.[all stents may be subject to varying degrees of encrustation when placed in the [all stents may be subject to varying degrees of encrustation when placed in the urinary tract.Encrustation may result in occlusion of the stent or pain or discomfort urinary tract.Encrustation may result in occlusion of the stent or pain or discomfort for the patient.]for the patient.] 2 2.Malfmalfunction and unction and aadverse dverse eeventsvents (1) (1) malfunmalfunctionction fragmentation, damagefragmentation, damage guidewire kinkingguidewire kinking difficulty in insertiondifficulty in insertion difficulty in removaldifficulty in removal occlusionocclusion migrationmigration encrustationencrustation difficulty in removal of the stent due to knotting of the coildifficulty in removal of the stent due to knotting of the coil 11)) ( (2) 2) adverse events adverse events edemaedema loss of renal functloss of renal functionion extravasationextravasation pain/discomfortpain/discomfort fistula formationfistula formation perforation of kidney, renal pelvis, ureter and/or bladderperforation of kidney, renal pelvis, ureter and/or bladder hemorrhagehemorrhage peritonitisperitonitis hydronephrosishydronephrosis infectioninfection stone formationstone formation urethral erosionurethral erosion urethral refluxurethral reflux separated piece remaininseparated piece remaining in bodyg in body urinary symptomsurinary symptoms 6 [storage method and expiration date] 1.Storage store in a dry, cool place away from heat, moisture, and direct sunlight.2.Expiration date indicated on the direct package and the outer box." corrections: d,f,h h11: section a through f - 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.H3 other text : the actual/suspected device was evaluated.
|
