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

Catalog Number 231045

Device Problems Partial Blockage (1065); Device Contamination with Body Fluid (2317)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that ureteral access sheath was blocked during stone surgery.So, the guide wire could not enter.

Event Description

It was reported that ureteral access sheath was blocked during stone surgery.So, the guide wire could not enter.

Manufacturer Narrative

The reported event is confirmed cause unknown.Visual evaluation noted the sample was provided with the original bard pouch inside a large ziploc bag.The dilator was inserted into the sheath when received.Visual requirements state to use 12" to 18" distance under normal room lighting unless otherwise noted.The sample had been sliced to determine where the foreign matter source.It could be seen that the sample had been used due to the buildup inside of the sample.Also received 2 photo samples.First photo sample shows dilator within packaging.Second photo sample shows top view of dilatator.Dimensional evaluation noted dimensional requirements states the guidewire is to be 0.038" ± 0.001", stepped od to be 0.127" ± 0.001", tube id to be 0.123" ± 0.002", and tip id to be 0.040" ± 0.001".The stepped od measured at 0.1280" using a laser micrometer.The tube od measured at 0.1220" using a laser micrometer.The tip id was measured using 0.040" pin gauge.The sample passed all the dimensional requirements.The potential root cause for this type of failure could be user unfamiliar with device or procedure.However, there was insufficient information to confirm this potential root cause.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: "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: hydrophiliccoated dilator with female luer connector hydrophiliccoated 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 anticoagulation's.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 resterilization 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.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: 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.Ensure the dilator lock is securely engaged with sheath hub prior to insertion.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.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.An endoscope and/or related instruments can now be used through the ureteral sheath as needed.If desired, irrigation can be applied using the luer connector on the dilator.Upon completion of the access procedure, gently withdraw the device.Discard the device in accordance with hospital procedures and with applicable laws and regulations." 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.

• Brand Name: PROXIS¿ URETERAL ACCESS SHEATH
• Type of Device: URETERAL ACCESS SHEATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18318594
• MDR Text Key: 330383657
• Report Number: 1018233-2023-08911
• Device Sequence Number: 1
• Product Code: FED
• UDI-Device Identifier: 00801741101694
• UDI-Public: (01)00801741101694
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K160861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 231045
• Device Lot Number: BMHSFM17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other