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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PROXIS URETERAL ACCESS SHEATH; URETER ACCESS SHEATH
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C.R. BARD, INC. (COVINGTON) -1018233 PROXIS URETERAL ACCESS SHEATH; URETER ACCESS SHEATH Back to Search Results
Model Number 231245
Device Problem Flaked (1246)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd 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 bd.
 
Event Description
It was reported that a urethral catheter sheath was inserted to establish access, when performing lithotripsy under flexible ureteroscope.It was stated that after the flexible ureteroscope was inserted, materials on the inner wall of the sheath came off.
 
Manufacturer Narrative
The reported event was confirmed however the cause was unknown.One sample was confirmed to exhibit the reported failure.It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.A potential root cause for this failure could be "user unfamiliar with device or procedure; user technique".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: "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." corrections: d, h.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 actual/suspected device was inspected.
 
Event Description
It was reported that a urethral catheter sheath was inserted to establish access, when performing lithotripsy under flexible ureteroscope.It was stated that after the flexible ureteroscope was inserted, materials on the inner wall of the sheath came off.
 
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Brand Name
PROXIS URETERAL ACCESS SHEATH
Type of Device
URETER ACCESS SHEATH
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key11229323
MDR Text Key228648735
Report Number1018233-2021-00124
Device Sequence Number1
Product Code FED
UDI-Device Identifier00801741101724
UDI-Public(01)00801741101724
Combination Product (y/n)N
PMA/PMN Number
K160861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 09/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/05/2023
Device Model Number231245
Device Catalogue Number231245
Device Lot NumberBMENFM17
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2021
Date Manufacturer Received09/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
Patient Weight80
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