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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
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The reported event is inconclusive.Visual: the sample was provided with the original bard inlay box and pouch front, inside a large ziploc bag.The suture and pigtail straightener were not provided.Visual requirements state to use unaided eye at 12" to 18" distance under normal room lighting unless otherwise noted.Dimensional: dimensional requirements state the od is to be 0.079" ± 0.002", the tip id is to be 0.043" ± 0.002", and the guidewire to be 0.038" ± 0.001".The sample passed the visual requirements and no defect could be evaluated.The sample did appear to be used due to the residue on the outside and inside of the stent.The sample passes all dimensional requirements.The od was measured at 0.0807" using a laser micrometer.The tip id was measured using a 0.043" pin gauge.The sample passed along a 0.038" guidewire with no hesitation.The exact root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be material selection.However, there was insufficient information to confirm this potential root cause.A dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and state the following: ¿inlay optima® ureteral stent coated double pigtail ureteral stent with suture inlay optima® multi-length ureteral stent coated double pigtail ureteral stent with suture federal (usa) law restricts this device to sale by or on the order of a physician.Indications for use: the inlay optima® ureteral stent and multi-length ureteral stent with suture are indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter.These conditions include stones and/or stone fragments, or other ureteral obstructions such as those associated with urethral structure.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.It is recommended that the indwelling time not exceed 365 days.The stent is not intended as a permanent indwelling device.Description: the inlay optima® ureteral stent and multi-length ureteral stent is a coated, double pigtail available in two forms: a single size or a customizable multi-length size.The following items are included with each stent: 1 ureteral stent with suture 1 push catheter with radiopaque band 1 pigtail straightener 1 guidewire* (optional) *note: a 4.7 fr stent is compatible with a.035¿ guidewire and 6, 7, and 8 fr stents are compatible with a.038¿ guidewire.In vitro testing conducted on the inlay optima® ureteral stent and multi-length ureteral stent indicate reduced accumulation of urine calcium salts as assayed by calcium when compared to a control.Correlation of in vitro data to clinical outcome has not been established.Contraindications: no known contraindications for use.Precautions: ¿ suture may be cut off prior to stent placement.Remove suture if indwelling time is expected to be longer than 14 days.The overall integrity of the stent.¿ 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 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.* ¿ 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.¿ care should be exercised when removing the stent from the inner polybag to eliminate tearing or fragmentation.¿ 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.¿ 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 encountered during attempts at removal.Potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: ¿ edema ¿ stone formation ¿ peritonitis ¿ 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 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.Packaging.**multi-length ureteral stent placement: to accurately size this stent count the marker bands 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.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.This is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.¿ correction: d,h 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 actual/suspected device was inspected.
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