MAUDE Adverse Event Report: BALT USA HYBRID GUIDEWIRE

Model Number	HYBRID1214D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the physician was selecting a distal vessel off the eca with the hybrid wire, upon pulling the wire back into the micro in order to shoot a contrast injection, it appeared the tip of the hybrid had broke off.The entire micro-catheter had to be removed in order to get the wire out.Once completely out of the body, the suspicision that the wire had broke was correct.The wire is available for return." incident report form submitted for this complaint indicates that no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference # (b)(4).Conclusion of investigation pending analysis from supplier, balt extrusion.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
Additional Manufacturer Narrative
Balt usa reference # (b)(4).As you are aware, the affected device was not returned & therefore, we could only base our analysis on the incident description you filled, the post-market surveillance (pms) data, and the internal investigations we conducted (lot history record, quality controls, etc.).During the manufacturing process, several tests are performed: - two different destructive tests by sampling are performed: wire twisting and bending - all units are tested with a non-destructive bending test.- the aspect of the welding is 100% controlled.Nor the internal investigations (lhr & quality control reviews), nor the pms data highlighted anomalies which could explain the issue you experienced during the procedure.As such, we lack information to draw a solid conclusion on the root cause of the incident.Please be sure we will continue monitoring this failure mode as part of our post-market surveillance process.A comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.No such increase in the rate of occurrence has been observed.However, this issue will remain subject to continued tracking.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
Event or Problem Description
It was reported that: "the physician was selecting a distal vessel off the eca with the hybrid wire, upon pulling the wire back into the micro in order to shoot a contrast injection, it appeared the tip of the hybrid had broke off.The entire micro-catheter had to be removed in order to get the wire out.Once completely out of the body, the suspicision that the wire had broke was correct.The wire is available for return." incident report form submitted for this complaint indicates that no patient injury was sustained.

• Brand Name: HYBRID GUIDEWIRE
• Common Device Name: HYBRID
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer (Section G): BALT EXTRUSION; 10 rue de la croix vigneron; montmorency, 95160 ; FR 95160
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 22589051
• Report Number: 3014162263-2025-00052
• Device Sequence Number: 21120720
• Product Code: MOF
• UDI-Device Identifier: 00818053022784
• UDI-Public: (01)00818053022784(11)230913(17)280828(10)00530149
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K182337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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 Model Number: HYBRID1214D
• Device Lot Number: 00530149
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2023
• 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