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

Catalog Number	150NSA35
Medical Device Problem Codes	Flaked (1246); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire was sold by the company to (b)(6) hospital in (b)(6) on (b)(6) 2025.On (b)(6) 2025, when (b)(6) hospital was using the guide wire, they opened the packaging, took out the guide wire, and found that the tip of the guide wire was split.That day, the hospital contacted the company and also provided detailed information to the company on (b)(6) 2025.
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 is confirmed cause unknown.Visual evaluation noted received nitinol guidewire.The coating was detached from the guidewire.Also received one photo sample that shows tip of guidewire with guidewire exposed and coating is flaking off.Labeling was found to be adequate.Dhr review did not show any problems or conditions that would have contributed to the reported event.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 the guidewire was sold by the company to (b)(6) hospital in (b)(6) on (b)(6) 2025.On (b)(6) 2025, when (b)(6) hospital was using the guide wire, they opened the packaging, took out the guide wire, and found that the tip of the guide wire was split.That day, the hospital contacted the company and also provided detailed information to the company on (b)(6) 2025.

• 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: 22853454
• Report Number: 1018233-2025-06924
• Device Sequence Number: 12867133
• Product Code: EZB
• UDI-Device Identifier: 00801741051500
• UDI-Public: (01)00801741051500(11)240523(17)290228(10)NGJQ0964
• 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): 10/10/2025

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: 150NSA35
• Device Lot Number: NGJQ0964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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