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The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "align® urethral support system manufacturer: bard c.R.Bard, inc.Covington, ga 30014 usa 1-800-526-4455 www.Bardmedical.Com bard limited, forest house brighton road crawley, west sussex rh11 9bp, uk 0044 1293 527 888 sterilized by ethylene oxide read instructions for use.Single use only.Do not reuse.Do not resterilize sterile unless package is opened or damaged.Use by date date of manufacturer batch code manufacturer catalogue number caution: federal (usa) law restricts this device to sale by or on the order of a physician.Authorized representative align® urethral support system english caution: federal (usa) law restricts this device to sale by or on the order of a physician.This product is intended for use only by physicians trained in the surgical procedures and techniques required for the treatment of female stress urinary incontinence and the implantation of nonabsorbable meshes.The physician is advised to consult the medical literature regarding techniques, complications, and hazards associated with the intended procedures.Description the align® retropubic/suprapubic/retropubic-suprapubic (r/s/rs) urethral support system (align® urethral support system) is a suburethral sling device intended for the treatment of female stress urinary incontinence.The system consists of stainless steel introducers and a polypropylene mesh sling implant encased in a protective sheath with green guide tubes at each end of the sheath.Connectors are attached to the distal ends of the guide tubes, and are designed to attach to the tip portion of the introducer needles.The device is terminally sterilized by ethylene oxide.Indications for use the align® urethral support system is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.Contraindications the align® urethral support system is contraindicated for patients experiencing any of the following conditions: pregnancy, urinary tract infection, anticoagulant therapy, and/or infection in the operative field.Warnings - the implant procedure and the instrumentation associated with the surgical placement of the align® urethral support system carry an inherent risk of infection and bleeding, as do similar urological procedures.The use of surgical staples, clips, screws, or other non-suture attachment mechanisms not supplied with the align® urethral support system can damage the implant.- after use, the product and its packaging should be treated as a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.Precautions the usual precautions associated with urological procedures should be followed: - based on physician experience and training, a thorough assessment of each patient should be made to determine their suitability for the implant procedure.Additional consideration should be given to use of the implant in patients with a compromised immune system, any condition that would compromise healing, or any patient with a history of prior abdominal or pelvic surgeries.Consideration should also be given to the ability of the patient to tolerate the surgical procedure.- accepted surgical practice and precautions must be followed for the management of contaminated or infected wound sites, when the align® urethral support system is used.- postoperative bleeding may occur in some patients and must be controlled prior to patient release.- the implant procedure requires diligent attention to anatomical structures and care to avoid puncture of large vessels, nerves, bladder, bowel, urethra and any viscera, during introducer passage.- cystoscopy should be performed to confirm bladder integrity or recognize a bladder perforation.- due to anatomical distortion that can be caused by pelvic organ prolapse, if the patient requires cystocele repair, it should be performed prior to the implantation of the sub-urethral sling.- proper placement of the sling implant at mid-urethra requires that it lie flat with minimal or no tension under the urethra.- the align® urethral support system is intended as a single-use device.Do not re-sterilize any portion of the align® urethral support system.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.- patients should be advised that pregnancy following a mesh sling implant procedure may negatively affect the success of the previous implant procedure and incontinence may recur.- the safety and effectiveness of the align® urethral support system implant procedure has not been established for the treatment of stress urinary incontinence in males or children under the age of 18.- check the integrity of the packaging before use.Do not use the align® urethral support system if the packaging is opened or damaged.- as for any implantable material, it is recommended to open the package at the time of implantation.- post-operatively the patient should be advised to refrain from heavy lifting, exercise (e.G.Cycling, jogging) and/or intercourse until the physician determines it is suitable for the patient to return to normal activities.Adverse events complications associated with the proper implantation of the align® urethral support system may include, but are not limited to: - postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.- urinary retention, bladder outlet obstruction and other voiding dysfunctions.These conditions may be associated with overcorrection/ too much tension placed on the implant.- perforations or lacerations of vessels, nerves, bladder, bowel, urethra, or any viscera, which may occur during the implantation procedure.- irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.- extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa.- inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of incontinence.Implant procedure align® urethral support system may be implanted using local, regional, or general anesthesia.Operative preparation: 1.Position the patient in the lithotomy position and prepare for surgery using standard operative procedures.Insert foley catheter and drain the bladder until empty.2.Make two small abdominal incisions approximately 1.5cm on each side of the midline just above the pubic symphysis.3.Place allis clamps on the vaginal mucosa overlying the urethra.One clamp is placed approximately 1cm from the external urethral meatus and the other at the urethrovesical junction.4.Inject solution (i.E., 1% lidocaine with epinephrine) into the vaginal mucosa and periurethral tissue if desired.5.Make a small vertical incision in the anterior vaginal wall beginning approximately 1cm under the urethral meatus.Gently free the urethra from the anterior vaginal wall.6.Make 2 small paraurethral dissections bilaterally to prepare for introducer insertion.Introducer insertion and implant placement: the technique for implantation can be done via a retropubic (vaginal) or a suprapubic (abdominal) approach.The align® r urethral support system provides introducers for a retropubic approach.The align® s urethral support system provides introducers for a suprapubic approach.The align® rs urethral support system provides introducers for both a retropubic and a suprapubic approach.If using the align® rs system, the introducer needles are not pre-assembled into the handles.It will be necessary to insert the appropriate introducer needles into the handles prior to the procedure.To assemble, insert the end of the introducer needle into the opening in the front of the handle.Insert the introducer needle until an audible click is heard and it is firmly in place in the handle.Retropubic (vaginal) approach 1.Resting the tip of the introducer needle on the palmar surface of the non-dominant index finger, gently insert the introducer into one of the periurethral spaces and perforate the endopelvic fascia.Carefully guide the introducer needle through the space of retzius and perforate the rectus sheath and muscle.Guide the introducer needle by palpation into the abdominal incision until the introducer needle is exposed through the incision.A cystoscope or rigid catheter guide can be used to position the urethra and bladder away from the intended path of the introducer needle.2.While holding down on the button located in the middle of the handle, disconnect the handle from the introducer needle by sliding it away from the patient.Take care to stabilize the introducer needle as the handle is being removed.3.Grasp the connector between the thumb and index finger as indicated by the arrows in the image below.Attach the connector to the distal end of the introducer needle by pushing it straight onto the tip.Detectable feedback of the connection will alert the physician that the connector has been properly engaged.4.Grasp the introducer needle and draw the implant up through the abdominal incision until the beginning of the green guide tube can be visualized through the abdominal incision.5.Take care to ensure that the sheath assembly is not twisted and that the green mid-point tab is facing outward and is positioned suburethrally.6.Repeat steps 1-5 on the patient¿s contralateral side using the second introducer.7.At this point, the two green guide tubes will be in place and cystoscopy should be performed to confirm bladder integrity.8.The two ends of the green guide tube are used to draw the mesh within the protective sheath into position, placing the green midpoint tab loosely under the mid-urethra.The green guide tube may be cut with scissors or the connector can be detached from the introducer or may be left attached if desired.9.In order to remove the sheath, it is first necessary to grasp the two sides of the mid-point tab and peel them away from the center of the sheath as indicated by the arrows.The tab will then slide off of the two proximal ends of the sheath.10.Place a blunt instrument between the urethra and the mesh while adjusting and positioning the sling.When the appropriate tension is attained, remove the sheath to fully expose the mesh by pulling gently on both suprapubic ends of the sheath.Keep the blunt instrument in place under the urethra when removing the two ends of the sheath to ensure that over-tightening of the mesh does not occur.11.Cut the exposed mesh strips at the level of the subcutaneous tissue and close each skin incision.12.Close the vaginal incision.Suprapubic (abdominal) approach 1.Gently insert the introducer into one of the abdominal incisions.Using the posterior surface of the pubic bone, walk the introducer needle down toward the vaginal incision.A cystoscope or rigid catheter guide can be used to position the urethra and bladder away from the intended path of the introducer needle.2.Use the index finger of the other hand to meet the tip of the introducer needle, guiding it through the endopelvic fascia and into the vaginal incision.3.Grasp the connector between the thumb and index finger as indicated by the arrows in the image below.Attach the connector to the tip of the introducer needle by pushing it straight onto the tip.Detectable feedback of the connection will alert the physician that the connector has been properly engaged.4.Grasp the introducer needle or handle and draw the implant up through the abdominal incision until the beginning of the green guide tube can be visualized through the abdominal incision.5.Take care to ensure that the sheath assembly is not twisted and that the green mid-point tab is facing outward and is positioned suburethrally.6.Repeat steps 1-5 on the patient¿s contralateral side using the second introducer.7.At this point, the two green guide tubes will be in place and cystoscopy should be performed to confirm bladder integrity.8.The two ends of the green guide tube are used to draw the mesh within the protective sheath into position, placing the green midpoint tab loosely under the mid-urethra.The green guide tube may be cut with scissors or the connector can be detached from the introducer or may be left attached if desired.9.In order to remove the sheath, it is first necessary to grasp the two sides of the mid-point tab and peel them away from the center of the sheath as indicated by the arrows.The tab will then slide off of the two proximal ends of the sheath.10.Place a blunt instrument between the urethra and the mesh while adjusting and positioning the sling.When the appropriate tension is attained, remove the sheath to fully expose the mesh by pulling gently on both suprapubic ends of the sheath.Keep the blunt instrument in place under the urethra when removing the two ends of the sheath to ensure that over-tightening of the mesh does not occur.11.Cut the exposed mesh strips at the level of the subcutaneous tissue and close each skin incision.12.Close the vaginal incision.Note: if an introducer needle(s) need to be re-passed, follow the steps outlined below: 1.Measure roughly 1.0" behind the connector towards the sheath, and make a cut across the green guide tube.A hollow opening should now be visible inside of the green guide tube.2.Locate the slit opposite the d-window on the side of the connector.While grasping the connector between the thumb and index finger as before, apply force perpendicular to needle shaft to free needle through the slit.3.Slide the connector mechanism off of the introducer needle tip.4.Follow the introducer insertion steps outlined above to re-pass the introducer needle.5.Once the needle has been re-passed, push the green guide tube onto the introducer tip.Ensure that tube has been inserted completely onto the introducer tip and is securely attached.6.Follow the implant placement steps outlined above to complete the procedure.Supply the align® urethral support system is intended as a single-use, disposable device.Do not resterilize any portion of the align® urethral support system.The device is terminally sterilized by ethylene oxide.The align® urethral support system is supplied as a complete operative kit consisting of two stainless steel retropubic and/or suprapubic introducers and a polypropylene mesh implant sling encased in a protective sheath with green guide tubes and connectors at each end.Storage store at ambient temperature.Do not use the device past the last day of the labeled month of expiration.Upon receipt of shipment, ensure that the packaging is not open or damaged and retains its sealed integrity.Do not use the device if the integrity of the packaging appears compromised.Bard and align are trademarks and/or registered trademarks of c.R.Bard, inc.Or an affiliate.Copyright © 2009 c.R.Bard, inc.All rights reserved.Patents pending." 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 device was not returned.
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