MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PROXIS¿ URETERAL ACCESS SHEATH

Catalog Number	231035
Medical Device Problem Codes	Partial Blockage (1065); Difficult to Insert (1316); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire cannot pass through the dilater.A situation has occurred where adhesive was clogged inside the dilater, prevented guidewire from passing.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings, and no sample was available for evaluation.No actions can be taken at this time since a root cause was not identified.A dhr could not be performed since no lot number was provided.The instructions for use were found adequate and state the following: 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 proxis ureteral access sheaths are intended to be used in patients as determined by the physician.Intended clinical benefits: the intended clinical benefit of the ureteral access sheath is to allow continued ureteral access during endourological procedures while allowing irrigation during repeated device exchanges.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 anticoagulants.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.Warnings: this is a single use device.Do not resterilize 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.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal 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 use if the package is opened or damaged.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 damage the integrity of the device and result in patient injury.Do not advance or withdraw device if any resistance is encountered during placement or removal without determining cause and taking action.Current scientific evidence supports that medical devices manufactured from stainless-steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects.Adverse events: potential adverse events associated with the use of the transurethral access device includes, 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 users and/or patients within the european union, should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the member state in which the user and/or patient is established.Users outside of the european union should report any serious incident that has occurred in relation to the device to the manufacturer and the regulatory authority of the country in which the user and/or patient is established.Directions for use: 1.Inspect product/package for damage prior to use.2.Activate the hydrophilic coating by placing the dilator and sheath components into saline or sterile water.Place an 0.035" (0.889 mm) or 0.038" (0.965 mm) guidewire into the ureter using standard endourology techniques.3.Ensure the dilator lock is securely engaged with sheath hub prior to insertion.4.Insert the guidewire into the tapered end of the dilator/sheath assembly and gradually advance the assembly into the ureter.Placement of the assembly can be verified using fluoroscopy or radiographic means.5.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.Suture holes are provided on sheath hub for securing externally, if desired.6.An endoscope and/or related instruments can now be used through the ureteral sheath as needed.7.If desired, irrigation can be applied using the luer connector on the dilator.8.Upon completion of the access procedure, gently withdraw the device.9.Discard the device in accordance with hospital procedures and with applicable laws and regulations.For urological use only udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that the guidewire cannot pass through the dilater.A situation has occurred where adhesive was clogged inside the dilater, prevented guidewire from passing.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings, and no sample was available for evaluation.No actions can be taken at this time since a root cause was not identified.A dhr could not be performed since no lot number was provided.The instructions for use were found adequate and states the following: 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.Proxis ureteral access sheaths are intended to be used in patients as determined by the physician.Intended clinical benefits: the intended clinical benefit of the ureteral access sheath is to allow continued ureteral access during endourological procedures while allowing irrigation during repeated device exchanges.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 anticoagulants.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.Warnings: this is a single use device.Do not resterilize 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.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal 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 use if the package is opened or damaged.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 damage the integrity of the device and result in patient injury.Do not advance or withdraw device if any resistance is encountered during placement or removal without determining cause and taking action.Current scientific evidence supports that medical devices manufactured from stainless-steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects.Adverse events: potential adverse events associated with the use of the transurethral access device includes, 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.Users and/or patients within the european union, should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the member state in which the user and/or patient is established.Users outside of the european union should report any serious incident that has occurred in relation to the device to the manufacturer and the regulatory authority of the country in which the user and/or patient is established.Directions for use: 1.Inspect product/package for damage prior to use.2.Activate the hydrophilic coating by placing the dilator and sheath components into saline or sterile water.Place an 0.035" (0.889 mm) or 0.038" (0.965 mm) guidewire into the ureter using standard endourology techniques.3.Ensure the dilator lock is securely engaged with sheath hub prior to insertion.4.Insert the guidewire into the tapered end of the dilator/sheath assembly and gradually advance the assembly into the ureter.Placement of the assembly can be verified using fluoroscopy or radiographic means.5.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.Suture holes are provided on sheath hub for securing externally, if desired.6.An endoscope and/or related instruments can now be used through the ureteral sheath as needed.7.If desired, irrigation can be applied using the luer connector on the dilator.8.Upon completion of the access procedure, gently withdraw the device.9.Discard the device in accordance with hospital procedures and with applicable laws and regulations.For urological use only.Udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that the guidewire cannot pass through the dilater.A situation has occurred where adhesive was clogged inside the dilater, prevented guidewire from passing.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings, and no sample was available for evaluation.No actions can be taken at this time since a root cause was not identified.A dhr could not be performed since no lot number was provided.The instructions for use were found adequate and state the following: 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 proxis ureteral access sheaths are intended to be used in patients as determined by the physician.Intended clinical benefits: the intended clinical benefit of the ureteral access sheath is to allow continued ureteral access during endourological procedures while allowing irrigation during repeated device exchanges.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 anticoagulants.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.Warnings: this is a single use device.Do not resterilize 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.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal 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 use if the package is opened or damaged.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 damage the integrity of the device and result in patient injury.Do not advance or withdraw device if any resistance is encountered during placement or removal without determining cause and taking action.Current scientific evidence supports that medical devices manufactured from stainless-steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects.Adverse events: potential adverse events associated with the use of the transurethral access device includes, 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 users and/or patients within the european union, should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the member state in which the user and/or patient is established.Users outside of the european union should report any serious incident that has occurred in relation to the device to the manufacturer and the regulatory authority of the country in which the user and/or patient is established.Directions for use: 1.Inspect product/package for damage prior to use.2.Activate the hydrophilic coating by placing the dilator and sheath components into saline or sterile water.Place an 0.035" (0.889 mm) or 0.038" (0.965 mm) guidewire into the ureter using standard endourology techniques.3.Ensure the dilator lock is securely engaged with sheath hub prior to insertion.4.Insert the guidewire into the tapered end of the dilator/sheath assembly and gradually advance the assembly into the ureter.Placement of the assembly can be verified using fluoroscopy or radiographic means.5.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.Suture holes are provided on sheath hub for securing externally, if desired.6.An endoscope and/or related instruments can now be used through the ureteral sheath as needed.7.If desired, irrigation can be applied using the luer connector on the dilator.8.Upon completion of the access procedure, gently withdraw the device.9.Discard the device in accordance with hospital procedures and with applicable laws and regulations.For urological use only correction: f, h udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that the guidewire cannot pass through the dilater.A situation has occurred where adhesive was clogged inside the dilater, prevented guidewire from passing.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: f, h.Udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that the guidewire cannot pass through the dilater.A situation has occurred where adhesive was clogged inside the dilater, prevented guidewire from passing.

• Brand Name: PROXIS¿ URETERAL ACCESS SHEATH
• Common Device Name: ACCESS SHEATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 21832572
• Report Number: 1018233-2025-02619
• Device Sequence Number: 18452762
• Product Code: FED
• UDI-Device Identifier: 00801741101687
• UDI-Public: (01)00801741101687
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 231035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 07/07/2025; 07/14/2025; 07/16/2025; 08/20/2025
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 07/08/2025; 07/15/2025; 07/17/2025; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown