MAUDE Adverse Event Report: BALT USA PRESTIGE COIL SYSTEM

Model Number	PRES0103CXPPL
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 it was discovered that the retain label within the lhr of a lot undergoing qc inspection called out the incorrect dimension under dimension d on the prestige coil system label.Dimension d is the measurement of the first loop diameter.Dimension d should state 1 mm for model pres0103cxppl, however it states 3cm.Following this dicovery at qc, build records were reviewed since the point at which the error in the labeling database would have been active and there were 2 lots identified to have been built and released (lot #f220701373 (18 units) and lot #f220701428 (13 units)) with the same discrepancy.
Additional Manufacturer Narrative
Balt us internal reference: (b)(4).Two manufacturing lots were discovered in-house to have the incorrect dimension d listed on the product labeling.For these two manufacturing lots (f220701373 and f220701428), the dimension d indicates the size "3cm", however the correct dimension for this prestige model pres0103cxppl should indicate "1mm".The dimension d indicated on the prestige coil system labeling references the first loop diameter of the implant coil.The nominal loop (dimension a) and the straight coil length (dimension b) are correct on all of the affected product labels.A notice will be issued to the user facilities who have received the affected units for their awareness of the incorrect unit of measure and size indicated for the first loop diameter.Corrective action for the issue discovered in-house is being taken under balt usa reference capa-p-1061.

• Brand Name: PRESTIGE COIL SYSTEM
• Common Device Name: PRESTIGE
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 17981276
• Report Number: 3014162263-2023-00063
• Device Sequence Number: 17011916
• Product Code: KRD
• UDI-Device Identifier: 00818053027277
• UDI-Public: (01)00818053027277(11)220729(17)270729(10)F220701428
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220699
• 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): 10/19/2023

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: PRES0103CXPPL
• Device Lot Number: F220701428
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2023
• Date Device Manufactured: 07/29/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown