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The reported event was confirmed ¿ unknown cause.The reported failure was able to be reproduced.The product was used for urological care.The product had caused the reported failure.Visual inspection noted end of pigtail was cracked.The black suture was not returned.The exact cause of how and when the problem occurred could not be determined.Hence, the reported event is confirmed as unknown cause.The potential root cause for this failure mode could be due to user related or supplier (example: mishandling product/material brittle).A review of the device history record did not show any problems or condition that would have contributed to the reported issue.Therefore no additional action required at this time.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: [warnings] 1.Method for use (1)when using the multi-length typestent, it should be avoided in the following cases.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 stents with excessive coil part shave risks of knot formation at the tip of renal pelvis side during placement or removal.1) 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)uretero arterial 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®inlayoptimatmstentsetcomprises the following components.1.Bard®inlayoptimatmureteral stent the bard®inlayoptimatmureteral 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.[intended use & effect-efficacy] bard®inlay optimatmstent 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 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.2) prior to removing the guidewire from the guidewire holder, inject sterile water through the port to activate the hydrophilic coating.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) nephrouretero graphy 1) place the tigertailtmureteral catheterover 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 guide wire 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 (kidney 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 and pass the stent over the guidewire through the cystoscope by using the pusher with radiopaque 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 advancing to proper position of the stent.Hold the guidewire to keep it from moving.6) stop advancing when the stent¿s distal end is identified.If the proximal end is inserted too much, pull the suture to modify the stent properly.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.9) withdraw the guidewire.The stent will form a pigtail automatically 10) carefully remove the pusher.11) confirm position of the stent by fluoroscopy. 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 4 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.2 precaution's for use (1)when using the tigertailt mureteral catheter, especiallywithout the stabilizing support of a guidewire, be aware that a malfunction may occur where the flexible tip may detach if excessive force ismade 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.(2)do not withdraw the ureteral catheter while it is deflected in endoscope.(3)avoid sharp bendingof the ureteral catheter.(4)when performing drainage of urine, retrograde visualizations etc.Though the ureteral catheter, attach the ureteral catheter adapter to the tip of ureteral catheter.(5)do not over-tighten the catheter adapter.Over-tightening of the catheter adapter may occlude the lumen of the catheter. (1)do not forcibly insert or remove the stent.It may injure patient or/and damage this product.(2)avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could damage the overall integrity of the stent.(3)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 be caused by sharp instruments.(4)determine the proper stent length for the patient.Selection of too short a stent may result in migration.(5)in the event of stent migration, cystoscopy or ureteroscopy should be used to return the stent to the original position or remove from the patient body.(6)any signsof infection in the location of the stent placement require removal of the stent.After checking the condition of the patient, a new stent should be placed.(7)care should be exercised when removing the stent to eliminate tearing or fragmentation. (1)do not forcibly insert or remove the guidewire.It may injure patient or/and damage the device.(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 with sharp edges (such as metal dilator).(3)avoid using of the device when resistance is encountered (dueto the size of a catheter, stent and/or working-channel of endoscope) as this may cause wear the guidewire coating.(4)do not use organic medical solutions or oily contrast medium on this device.These solutions may damage the device or decrease the lubricity of the device.(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 coating can be damaged, increasing resistance when trying to insert catheter, stent or endoscope.] (6)if unusual resistance is met during manipulation of the guidewire, do not force to 5 remove it.Carefully withdraw the guidewire as a unit.(7)do not use a retrieval device while the guidewire is in place; to do so may cause damage to the guidewire.(8)don¿t rub the guidewire with the edgeof the holder.This could flake the hydrophilic coating.(9)avoid kinking, bending or twisting repeatedly the guidewire at acute bent site.It may lead to damage the guidewire.(10)never try to shape the guidewire.This could damage and break the cable coreof the guidewire.(11)sufficient guidewire length must remain exposed to maintain a firm grip on the guidewire at all times.[precautions] 1.Important precautions (1)the stent is not intended as a permanent indwelling device.It is recommended that the indwelling time not exceed 365 days.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.[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 for the patient.] 2.Malfunction and adverse events (1)malfunction ¿fragmentation, damage ¿guidewire kinking ¿difficulty in insertion ¿difficulty in removal ¿occlusion ¿migration ¿encrustation ¿difficulty in removal of the stent due to knotting of the coil1) (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 ¿urethral erosion ¿urethral reflux ¿separated piece remaining in body ¿urinary 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.The actual/suspected device was inspected.
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