MAUDE Adverse Event Report: BALT USA HYBRID GUIDWIRE

Model Number	HYBRID1214DA
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was identified during the investigation of supplier balt extrusion's health hazard evaluation process (balt extrusion hhe-030) that the product lot number 00521955 may have been impacted by a potential mix-up of products.For this lot number (00521955), the indicated hybrid guidewire model is hybrid1214da on the pouch and carton label.Following balt extrusion's investigation, it was noted that a potential device mix-up may have occurred with another manufacturing lot number (00520501) which corresponds to a different model/guidewire size (hybrid008j).
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.

• Brand Name: HYBRID GUIDWIRE
• 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: 18194814
• Report Number: 3014162263-2023-00072
• Device Sequence Number: 12691732
• Product Code: MOF
• UDI-Device Identifier: 00818053022791
• UDI-Public: (01)00818053022791(11)230308(17)280228(10)00521955
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2023

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
• Device Model Number: HYBRID1214DA
• Device Lot Number: 00521955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 11/22/2023
• 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