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

Catalog Number	150NSS35
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a patient underwent flexible ureteroscopy lithotripsy and stone removal for renal calculi.After initial placement of a guidewire and insertion of a single-use ureteral sheath, the guidewire proved difficult to extract.Upon removal, the guidewire surface coating was observed to be peeled off refer to actual sample and image.Following clinical assessment, a new ultra-smooth guidewire was selected, enabling successful completion of subsequent procedures.The surgery concluded without complications.Although surgical and anesthesia times were extended, no other adverse effects occurred.That hospital routinely uses ultra smooth guidewires, and such coating detachment was infrequent.Patient procedure time was extended no other impacts.A new ultra-slide guidewire was selected, and subsequent procedures were completed successfully.
Additional Manufacturer Narrative
(b)(6).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.

• 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: 24595767
• Report Number: 1018233-2026-01730
• Device Sequence Number: 9192537
• Product Code: EZB
• UDI-Device Identifier: 00801741051524
• UDI-Public: (01)00801741051524(17)291010(10)NGKS5775
• 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): 06/05/2026

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: NGKS5775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 06/16/2026
• 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