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The reported event was confirmed but the cause is unknown.The device failed to meet specifications.The device was being used for treatment.The evaluation report of the returned sample, submitted by futurematrix interventional, stated that a break in the stent was present on the kidney end (distal) of the stent located on the pigtail.The material of the stent at the break location showed no signs of stretching which occurs when pulling on the stent.The report also stated that there were currently three 100% inspections in place to check for noted issues.The report stated that the evaluation of all dhr's related to this complaint showed no out of specification results.Brittle material is considered as a potential root cause.Brittle material can be caused from material exposed to high temperatures during an oven malfunction or extruder / tipping equipment malfunction.Brittle material is ruled out due to temperature indicators inside of ovens; all settings are recorded on dhr and verified & calibration is current.Thin wall caused by large id and/or small od is considered as a potential root cause but is also ruled out due to qc measurement/verification.Damaged during porting is considered a potential root cause due to double punching, punch burred or punch-off center.Stent was visually observed under 7x magnification.Rupture indicates product is burst.Stents do not burst, therefore, break in stent is present on the kidney end (distal) of the stent located on the pigtail.The material of the stent at the break location shows no signs of stretching which occurs when pulling on the stent.Potential root cause is ruled out because all portholes are in proper location and md-7211-00 has 100% visual inspection under 7x-15x to check for damaged portholes.Nicked with a razor blade is considered a potential root cause.A razor blade is used at the beginning of processing when using ctl fixture ed-7538-xx.Nicked with a razor blade is ruled out because the razor blade is used in a controlled, spring loaded fixture.There is no other place in the process where razor blades are used beyond fixture ed-7538-xx.A 100% visual inspection under 7x-15x magnification to check for damage occurs in the process.Forming wire damaged is considered a potential root cause but is also ruled out because all portholes are in proper location and md-7211-00 has 100% visual inspection under 7x-15x to check for damaged portholes.End user is also a potential root cause.This cannot be ruled out due to uncertainty of force used to manipulate the stent during further packaging after leaving futurematrix facility or when removing the stent from the final packaging.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: ¿caution: federal (usa) law restricts this device to sale by or on the order of a physician.Note: 4.7 fr.Stent is.035¿ guidewire compatible.6, 7 and 8 fr.Stents are.038¿ guidewire compatible.Device description: the bard® inlay¿ double pigtail ureteral stent with suture is provided with a hydrophilic (lubricious) coating which aids in stent insertion and enhances patient comfort while indwell-ing and a monofi lament suture loop which aids in stent removal.Included are the following items: 1 lubricious double pigtail ureteral stent with suture.1 guidewire (unless ordered without guidewire).1 push catheter with radiopaque tip.1 pigtail straightener.1 information for use.The bard® inlay¿ versafit¿ ureteral stent with suture is provided with a hydrophilic (lubricious) coating which aids in stent insertion and enhances patient comfort while indwelling and a monofi lament suture loop which aids in stent removal.The multi-length feature allows the device to be fitted to most ureters (22-32cm).Included are the following items: 1 multi-length lubricious ureteral stent with suture.1 guidewire (unless ordered without guidewire).1 push catheter with radiopaque tip.1 pigtail straightener.1 information for use.Indications for use: the bard® inlay¿ and bard® inlay¿ versafit¿ ureteral stent with suture are indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with extracorporeal shock wave lithotripsy (eswl).The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.Contraindications: there are no known contraindications to use.Precautions: 1.For single use only.Do not resterilize.Do not use if the package or product is damaged.2.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.3.Suture may be cut off prior to stent placement.Remove suture prior to placement for pediatric patients.4.Exercise care.Tearing of the stent can be caused by sharp instruments.5.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 specificfactors.When long-term use is indicated, it is recommended that indwelling time not exceed 365 days.The stent is not intended as a permanent indwelling device.6.Care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation.7.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.8.The insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure.9.Multi-length ureteral stents: formation of knots in multi-length ureteral stents may occur.This may result in injury to the ureter during removal and/or the need for additional surgical intervention.The presence of a knot should be considered if significant resistance is encountered during attempts at removal.(data on file at c.R.Bard, inc.).Potential complications: potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: edema, stone, formation, peritonitis, extravasation, ureteral, refl ux, stent dislogdgement, fistula formation, loss of renal function, fragmentation, migration, occlusion hemorrhage, pain/discomfort, stent encrustation, hydronephrosis perforation of kidney, renal ureteral erosion, infection pelvis, ureter and/or bladder, urinary symptoms.Directions for use: 1.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.Submerge stent in sterile water to activate the coating.2.Insert the cystoscope then pass the guidewire through the scope until the tip is in the renal pelvis.3.Move the pigtail straightener over the proximal end (kidney coil end) of the ureteral stent allowing easier insertion onto the guidewire.Remove pigtail straightener once the stent is secure on the guidewire.4.Pass the stent over the guidewire through the cystoscope by using the push catheter for proper placement.5.Watch the distal end (bladder coil end) of the stent or the radiopaque, proximal end of the pusher.Stop advancing when the stent¿s distal end marker reaches the ureterovesical junction (uvj).(see below for proper placement directions on the multi-length ureteral stent.) 6.Withdraw the guidewire slowly.The stent will form a pigtail automatically.7.Carefully remove the push catheter.Activate the guidewire coating according to the ¿instructions for use¿ found within the guidewire packaging.Multi-length ureteral stent placement: to accurately size this stent count the marker bands as it is being advanced into the ureter.The first large band indicates the 22cm length.The second and third bands indicate 24cm and 26cm lengths respectively.The last large band is the 28cm length.If you need to place for the 30cm and 32cm lengths, use the attached suture or endoscopic forceps to gently pull back on the stent unwinding the coil from the kidney.Note: 1.Final adjustment, if necessary, can be made with endoscopic forceps.Stents can be removed easily by gentle withdrawal traction on the suture or by use of endoscopic forceps.2.Fluoroscopy facilitates stent placement; however, standard radiography may be used.3.The suture may be removed prior to placement or may be removed once indwelling by using an appropriate cystoscopic instrument.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and with applicable local, state and federal laws and regulations.U.S.Product packaged in mexico".H11:section a through f - the information provided by bd 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 bd.
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