MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 NICORE NITINOL GUIDEWIRE

Catalog Number	150NSS35
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that for the same patient undergoing the same procedure, after the guidewire was used to introduce the ureteroscope into the ureter, the guidewire was withdrawn.Subsequently, the guidewire surface exhibited wrinkles and became rough, rendering it unsuitable for guiding stent placement.Patient was exposed to bodily fluid.No medical intervention was reported.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation the reported event is addressed within the labeling as it state: warnings: - 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.- do not manipulate or remove the guidewire through a metal cannula or needle.This may result in destruction/separation of the outer jacket of the wire requiring retrieval.-use extreme caution when using a laser, making sure to avoid contact with the wire.Direct contact could result in damage / breakage to the wire.-attention should be paid to guidewire movement in the urinary tract.Before a guidewire is moved or torqued, tip movement should be examined under direct vision or fluoroscopy.- do not advance or withdraw a guidewire when resistance is encountered as perforation could occur.- sufficient guidewire length must remain exposed to maintain a firm grip on guidewire at all times.Direction of use: 2.Introduce the guidewire, flexible end first, into the working channel of the endoscopes or percutaneously into the urinary tract.3.Advance the guidewire slowly into the desired position.Continuously confirm guidewire position either visually or under fluoroscopy.4.Carefully withdraw the guidewire taking care not to kink.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Correction: d,e,f,h udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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.
Event or Problem Description
It was reported that for the same patient undergoing the same procedure, after the guidewire was used to introduce the ureteroscope into the ureter, the guidewire was withdrawn.Subsequently, the guidewire surface exhibited wrinkles and became rough, rendering it unsuitable for guiding stent placement.Patient was exposed to bodily fluid.No medical intervention was reported.

• Brand Name: NICORE NITINOL GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23209203
• Report Number: 1018233-2025-08784
• Device Sequence Number: 9139517
• Product Code: EZB
• UDI-Device Identifier: 00801741051524
• UDI-Public: (01)00801741051524(11)250129(17)291130(10)NGJZ1092
• 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): 11/25/2025

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 Catalogue Number: 150NSS35
• Device Lot Number: NGJZ1092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2025
• 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