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

Model Number	150NFA35
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
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 guide wire was damaged hence a new guide wire was used.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.No physical sample was returned however a photo sample was received.Based on the photo sample evaluation the device was observed to be flaking.A potential root cause for this failure mode could be due to inadequate material selection and or bonding between the layers or degradation.The lot number was unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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.Do not reshape the guidewire by any means.Attempting to reshape the guidewire may cause damage resulting in release of fragments into the urinary tract.Failure to exercise proper caution may result in damage to the urinary tract.Use extreme caution when using a laser, making sure to avoid contact with the wire.Direct contact could result in damage or breakage to the wire.Failure to comply with the warnings could result in damage to the guidewire to include, but not limited to: wire breakage, abrasion of the coating, release of guidewire fragments into the urinary system, all of which might require intervention." the actual/suspected device was inspected.
Event or Problem Description
It was reported that the guide wire was damaged.A new guidewire was used.

• Brand Name: NITINOL CORE GUIDEWIRE, .035", 3 CM, STRAIGHT, STANDARD, 150 CM LENGTH
• Common Device Name: 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: 11826502
• Report Number: 1018233-2021-02809
• Device Sequence Number: 19791276
• Product Code: EZB
• UDI-Device Identifier: 00801741051463
• UDI-Public: (01)00801741051463
• 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): 12/13/2021

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: 04/30/2022
• Device Model Number: 150NFA35
• Device Catalogue Number: 150NFS35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 12/15/2021
• 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