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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
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The reported event was unconfirmed since the perforated ureter could not be reproduced.The sample was received inside a clear ziploc bag with the customer's complaint number, part number and the lot number.The proxis sheath original package was folded inside the ziploc bag as well.The proxis sheath hub was printed 12/14f on both sides of the hub, the dilator was inserted into the sheath.While examining the proxis a dried clear substance was noticed on the outside of the sheath and when the dilator was removed from the sheath the dried clear substance was on it as well.During examination of the sheath's tip no damage was found.The entire od of the sheath was examined and found no surface damage or scratches.The same inspection was done on the dilator and found no scratches or damages.The dilator/sheath fit was also examined and found no issues with an unaided eye.The back lighting examined the id of the sheath from both ends and found no imperfections.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: "proxis ureteral access sheath instructions for use description: the proxis¿ ureteral access sheath is a two component ureteral dilation system which contains a single lumen for injection of fluids as well as passage of endoscopes and related instruments.The packaged product includes the following items: 1 - hydrophilic-coated dilator with female luer connector 1 - hydrophilic-coated sheath with hub indications for use: the proxis¿ ureteral access sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments.Contraindications: ¿ patients who are contraindicated for retrograde urological procedures.¿ patients who are contraindicated for antegrade urologic procedures, including but not limited to patients with blood clotting anomalies due to coagulopathies or pharmacological anticogagulations.¿ patients who have the presence of tight strictures which would limit use of the device.¿ patients who have the presence of large obstructing distal ureteral calculi.Warning: for single use only.Do not reuse, reprocess or resterilize.Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/ or lead to device failure, which in turn, may result in patient injury, illness or death.Reuse reprocessing or re-sterilization may also create a risk of contamination of the device and/or cause patient infection or crossinfection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.Contamination of the device may lead to injury, illness or death of the patient.Do not use if sterile barrier is damaged.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and with applicable laws and regulations.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Precautions: the recommendations given are meant to serve only as a basic guide to the utilization of this access sheath.The ureteral access sheath should not be used without comprehensive knowledge of the indications, techniques and risks of the procedure.To minimize resistance during advancement, ensure the hydrophilic coating on the dilator and sheath is activated with saline or sterile water prior to placement.Do not advance sheath without the dilator in place as this could lead to trauma or injury to patient.Do not bend the device prior to placement as this could do not advance or withdraw device if any resistance is encountered during placement or removal without determining cause and taking action.Adverse events potential adverse events associated with the use of the transurethral access device include, but are not limited to: - mucosal irritation, inflammation and edema - urethral strictures - acute bleeding or hemorrhage - urethral, bladder, or ureteral perforation - other injury to the urinary tract directions for use: 1.Activate the hydrophilic coating by placing the dilator and sheath components into saline or sterile water.Place an 0.035" (0.889mm) or 0.038" (0.965mm) guidewire into the ureter using standard endourology techniques.2.Ensure the dilator lock is securely engaged with sheath hub prior to insertion.3.Insert the guidewire into the tapered end of the dilator/sheath assembly and gradually advance the assembly into the ureter.Note: placement of the assembly can be verified using fluoroscopy or radiographic means.4.While maintaining sheath position, disengage the dilator lock from the sheath hub to gently remove the dilator.Do not advance sheath without the dilator in place.Note: suture holes are provided on sheath hub for securing externally, if desired.5.An endoscope and/or related instruments can now be used through the ureteral sheath as needed.6.If desired, irrigation can be applied using the luer connector on the dilator.7.Upon completion of the access procedure, gently withdraw the device.8.Discard the device in accordance with hospital procedures and with applicable laws and regulations.For urological use only manufactured and packaged in u.S.A.Bard and proxis are trademarks and/or registered trademarks of c.R.Bard, inc.©2016 c.R.Bard, inc.All rights reserved." correction: mfr site.
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