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The reported event was inconclusive because no sample was returned.It was unknown whether the device had met relevant specifications.It was unknown whether the product had caused the reported failure.The potential root cause for this failure mode could be defects component from supplier.The dhr review could not be performed without a lot number.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 otherstent which has different shape of tip and length.Ureteral stents with excessive coil partshaverisks 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 ofthe resistance with fluoroscopy and take remedial action to solve the problem.Excessive forceduring 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.[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 havewithout side hole.Bard®inlay optimatmstent (multi-length type) bard®inlay optimatmstent stent (double j type) side hole pigtail straightener scale (5 cm) length of stent (shaft) ureteral catheter adaptor [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.3 [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) inject physiological saline solution into the luer of the protectivehoop in order to completely wet the surface of the guidewire.2) remove the guidewire from the protective hoop.3) insert the guidewire either through the working channel of an endoscope or percutaneously, with the soft end of the guidewire first.4) 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 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 guidewireagain 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 tipfor 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 advancingtoproper position of the stent.Holdtheguidewire tokeep it from moving.6) stop advancing when the stent¿s distal end is identified.If the proximal endis inserted too much, pull the suture to modify the stent properly.7) confirm proximal end of the pusherand 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.Precautions for use (1)when using the tigertailtmureteral catheter, especiallywithout 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 ofthe 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 ofthe 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)suture can be cut off prior to stent placement.Remove suture prior to placement for pediatric patients.Remove suture if indwelling time is expected to be longer than 14 days.(6)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.(7)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.(8)care should be exercised when removing the stent to eliminate tearing or fragmentation. (1)when wetting the surface of the guidewire, use of alcohol, antiseptic solution or other solvents must be avoided [alcohol, antiseptic solution or other solvents may adversely affect the surface of the guidewire.] (2)save the hoop to store the guidewire if it will be used again during the same procedure on the same patient.When reinserting the guidewire back into the holder, take care not to damage the wire¿s coating with the edge of the holder.(3)do not wipe the guidewire with dry gauze etc.(4)keep at least 5 cm of the wire extended out of the proximal end of the scope or catheter during introduction at all times.(5)before inserting the guidewire through a catheter, fill the catheter with physiological saline solution.(6)the guidewire should be advanced through the scope using short, deliberate 2-3 cm 5 movements to prevent inadvertent damage to the device or patient.(7)if any resistance is felt during introduction of the catheter, it is advisable to stop using such catheters.[due to variations of certain catheter tip inner diameters, abrasion of the hydrophilic coating may occur during manipulation.] (8)after removal from the patient¿s urinary system, and prior to reinserting it into the same patient during the same catheterization, hydrophilic tipped guidewires should be rinsed in a bowl full of physiological saline solution.Use of alcohol, antiseptic solutions or other solvents must be avoided.[use of alcohol, antiseptic solutions or other solvents may adversely affect the surface of the guidewire.] [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.] (1)do not withdraw the guidewire through a metal cannula or needle.Extreme caution should be observed when used with one-wall puncture style needle.[withdrawal through a metal device may result in disposition of these materials in the urinary system and destruction and/or separation of the outer polymer jacket requiring retrieval.] (2)use extreme caution when using a laser or electrocautery, making sure to avoid contact with the guidewire.[direct contact may cause damage to the wire and/or sever the wire.] (3)do not use a torque device with the guidewire.[use of a torque device may result in damage to the wire.] (4)do not reshape the guidewire in any way.[attempting to reshape the wire may cause damage, resulting in the release of wire fragments to the urinary system.] (5)when exchanging or withdrawing a catheter over the guidewire, secure and maintain the guidewire in place under fluoroscopy to avoid unexpected guidewire advancement.[damage to the urinary channel by the wire¿s tip may occur.] (6)manipulate the guidewire slowly and carefully in the urinary system while confirming the behavior and location of the wire¿s tip under fluoroscopy.If any resistance is felt or if the tip¿s behavior and/or location seems improper, stop manipulating the guidewire and/or the catheter and determine the cause by fluoroscopy.If necessary, remove the guidewire and ancillary device or scope as a complete unit to avoid complications.[excessive manipulation of the guidewire without fluoroscopic confirmation may result in perforation or trauma of the linings or associated tissues, channels or ducts.Failure to exercise proper caution may result in bending, kinking, and separation of the guidewire¿s tip, damage to the catheter, or damage to the urinary system.] 2.Malfunction and adverse events (1)malfunction ¿fragmentation, damage6 ¿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, urinary tractand/or bladder ¿hemorrhage ¿peritonitis ¿hydronephrosis ¿infection ¿stone formation ¿urethral erosion ¿urethral reflux ¿separated piece remaining in body ¿tissue trauma ¿ureter avulsion ¿urinary symptoms" h11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.
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