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

Model Number	231045
Medical Device Problem Codes	Accessory Incompatible (1004); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
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 flexible mirror was unable to be inserted into the access sheath.The user stated that for another product of the same size, there was no problem.
Event or Problem Description
It was reported that the flexible mirror was unable to be inserted into the access sheath.The user stated that for another product of the same size, there was no problem.
Additional Manufacturer Narrative
The reported event was unconfirmed as the reported failure could not be reproduced.Photo samples were submitted by the customer which showed the hub separated from the rest of the sample; the complaint defect could not be evaluated based on the photos.The used access sheath was returned without the packaging.Visual inspection noted the sample had been used as some residue was left on and in the access sheath.No other defects were noted other than the separated hub.The proximal and distal inner diameter were measured with a pin gage and found to be 0.131" and 0.128", respectively.The hub dimensions measured 0.0167" and 0.134" and each end.All measurements were within specifications.The 0.128" mandrel passed through the sheath with no resistance, confirming clear passage.The device was used for treatment purposes.The device history record review was not required as the reported event was unconfirmed.The label/packaging review was not required as the reported event was unconfirmed.The actual/suspected device was inspected.

• Brand Name: PROXIS¿ URETERAL ACCESS SHEATH
• Common Device Name: 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13534781
• Report Number: 1018233-2022-00619
• Device Sequence Number: 5148207
• Product Code: FED
• UDI-Device Identifier: 00801741101694
• UDI-Public: (01)00801741101694
• 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
• Report Date (Section B): 05/20/2022

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 Expiration Date: 06/14/2024
• Device Model Number: 231045
• Device Catalogue Number: 231045
• Device Lot Number: BMFTFM08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• 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