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

Model Number	231245
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Patient Problem/Medical Problem (2688)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that the access sheath was not able to move smoothly during the procedure.The user removed the device to find the patient had urethral mucosal damage.Per additional information from the ibc via email 25nov2019, it is unknown if the patient required any further medical intervention, and it is unknown the condition of the access sheath before the procedure occurred (was the sheath smooth, rough, etc.).
Event or Problem Description
It was reported that the access sheath was not able to move smoothly during the procedure.The user removed the device to find the patient had urethral mucosal damage.It was later reported from the international business center via email (b)(6) 2019 that it is unknown if the patient required any further medical intervention, and it is unknown the condition of the access sheath before the procedure occurred (was the sheath smooth, rough, etc.).
Additional Manufacturer Narrative
The reported event was unconfirmed.Evaluation report of the returned sample, submitted by futurematrix interventional, stated that when the dilators were removed from the sheaths and reinserted using one hand, no resistance was felt.All 3 dilators were easily inserted into the respective sheaths.When the dilators and sheaths were tested in congo red to verify coating, it was indicated that the dilators and sheaths were coated properly.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.For urological use only" h11:section a through f - 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.

• Brand Name: PROXIS¿ URETERAL ACCESS SHEATH
• Common Device Name: URETER ACCESS SHEATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9440115
• Report Number: 1018233-2019-07836
• Device Sequence Number: 14353566
• Product Code: FED
• UDI-Device Identifier: 00801741101724
• UDI-Public: (01)00801741101724
• 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: distributor,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2022
• Device Model Number: 231245
• Device Catalogue Number: 231245
• Device Lot Number: BMDQFM22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention