MAUDE Adverse Event Report: BALT USA HYBRID GUIDEWIRE

Model Number	HYBRID007J
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was discovered during routine incoming quality control inspection on october 16, 2023, that the hybrid007j label (lb-0047 rev.D) on lot 00540774 had a labelling discrepancy.Dimension c denotes the od of the proximal wire, and had it listed as 0.12" (0.30mm), however the correct specification is 0.012" (0.30mm).
Additional Manufacturer Narrative
Balt usa internal reference: (b)(4) it was discovered during routine incoming quality control inspection on october 16, 2023, that the hybrid007j label (lb-0047 rev.D) on lot 00540774 had a labelling discrepancy.Dimension c denotes the od of the proximal wire, and had it listed as 0.12" (0.30mm), however the correct specification is 0.012" (0.30mm).All of the lots listed below were impacted by this label discrepancy.Those lots contain a total of 1372 devices.An informative letter will be sent to the customers that were distributed devices in the lots contained.Corrective action for the issue discovered in-house is being taken under balt usa reference capa-v-1041.Section d4 (lot numbers): 00335653, 00377894, 00347895, 00336387, 00372425, 00394312 , 00403909, 00404406, 00404992 , 00434345 , 00439632 , 00442692, 00463289, 00468462 , 00470334, 101818a, 102318a , f200600159 , f200600160 , f200800099 , f210300127, f210600189 , 00500440 , 00501693 , 00503011 , 00520108, 00521652 , 00524063, 00527200, 00533305, 00540774.

• 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 92618 ; 9497881443
• MDR Report Key: 18165348
• Report Number: 3014162263-2023-00069
• Device Sequence Number: 6541360
• Product Code: MOF
• UDI-Device Identifier: 00818053022746
• UDI-Public: 00818053022746
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 11/13/2023

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
• Operator of Device: Health Professional
• Device Model Number: HYBRID007J
• Device Lot Number: SEE MANUFACTURER NARRATIVE H10
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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