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

Model Number	231045
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
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 when the surgeon progressed the rirs (retrograde intrarenal surgery) procedure, found out the crumpled part on the end of sheath for proxis and also wanted to know why it occurred and mentioned that proxis had caused a severe damage to the flexible urs scope.
Additional Manufacturer Narrative
The reported event was unconfirmed as the device met the specifications.The access sheath was returned without the original packaging.No defects were noted on the sheath or dilator.The outer diameter of the sheath was measured and found to be 0.156", the distal inner diameter measured 0.128"; both results were within specifications.The stepped outer diameter of the dilator measured 0.126" and the tube outer diameter measured 0.121"; both readings were within specifications.A 0.038 passed through confirming clear passage.As the reported event is unconfirmed, a dhr review and label/packaging review is not required.However one was completed as the information in the entry description suggests the customer violated the ifu."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 re-sterilization 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." the actual/suspected device was inspected.
Event or Problem Description
It was reported that when the surgeon progressed the rirs (retrograde intrarenal surgery) procedure, found out the crumpled part on the end of sheath for proxis and also wanted to know why it occurred and mentioned that proxis had caused a severe damage to the flexible urs scope.

• 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: 12042425
• Report Number: 1018233-2021-03700
• Device Sequence Number: 17019854
• Product Code: FED
• UDI-Device Identifier: 00801741101694
• UDI-Public: (01)00801741101694
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K160861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2021

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: 12/17/2023
• Device Model Number: 231045
• Device Catalogue Number: 231045
• Device Lot Number: BMEYFM17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 11/06/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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