MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 NITINOL CORE GUIDEWIRE, .035", 3 CM, ANGLED, STIFF, 150 CM LENGTH; BARD NITINOL GUIDEWIRE

Model Number	150NSA35
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
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 the outer package of the nitinol guidewire product was checked for integrity prior to use and no abnormalities were found.After the outer package was opened, the steel wire of the guide wire at the tip was exposed.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.A photo sample was submitted by the customer showing the exposed core wire.The physical sample was also returned in the opened original packaging.An evaluation of the physical sample was completed by tommy st.Vincent of memory corporation on 24feb2022.Visual inspection noted the sample had a damaged tip.The exposure and damage do not show any signs of probable cause from the manufacturing processes.A review inspection records was performed by the supplier and no issues or internal ncr were found that could have caused or contributed to the reported event.A potential root cause for this event could be, "inappropriate package design.As no patient involvement was reported the device was not used, however, it is intended for treatment purposes.It is unknown if the device had met all relevant specifications, however, as damage was noted on the device resulted in the reported event.No manufacturing discrepancies were found in the dhr review that could have contributed to the.Reported issue.Based on the results of the investigation, no additional action is required at this time.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: "warning: inspect all guidewires for damage prior to use.Bending or kinking during or prior to placement could damage the guidewire.Do not attempt to use the guidewire if it has been damaged.Use of a damaged wire may result in damage to the urinary tract." the actual/suspected device was inspected.
Event or Problem Description
It was reported that the outer package of the nitinol guidewire product was checked for integrity prior to use and no abnormalities were found.After the outer package was opened, the steel wire of the guide wire at the tip was exposed.

• Brand Name: NITINOL CORE GUIDEWIRE, .035", 3 CM, ANGLED, STIFF, 150 CM LENGTH
• Common Device Name: BARD NITINOL GUIDEWIRE
• 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: 12417691
• Report Number: 1018233-2021-05387
• Device Sequence Number: 4649056
• Product Code: EZB
• UDI-Device Identifier: 00801741051500
• UDI-Public: (01)00801741051500
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

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: Lay User/Patient
• Device Expiration Date: 08/16/2024
• Device Model Number: 150NSA35
• Device Catalogue Number: 150NSA35
• Device Lot Number: NGET0766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 02/26/2022
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2020
• 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