MAUDE Adverse Event Report: BALT USA PRESTIGE COIL SYSTEM

Model Number	PRES0865CPKPLT
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference: #(b)(4).An evaluation of the actual complaint sample could not be performed as device was unavailable to be return.Based on the provided information, root cause could not be definitively determined.Lack of device return prevented deeper evaluation of the reported issue.Review of the lot history records did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number f250100769 has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.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: "pres0865cpkplt - in a gonadal case with dr (b)(6) on (b)(6) 2025 we used several prestige coils.The final coil that we used deployed early in the 2.4 progreat microcatheter.It sounds like dr (b)(6) and the ir tech felt some resistance during the deployment.70% of the coil deployed correctly in the vessel but the last 30% deployed early and didn't coil properly, the end result being a tail floating in the renal vein above the rest of the coils in the gonadal vein.Dr (b)(6) tried to push the tail of the coil with a wire and with a balloon but was unable to sufficiently move the coil.She felt that the coil was secure enough and wouldn't travel because the initial 70% of that coil correctly deployed and was secure." incident report form submitted for this complaint indicates that no patient injury was sustained.Update 11apr2025- additional information received from the issuer: "1.Any updates on the patient? - i reached out to dr (b)(6) today and she said the patient was fine when they went home tuesday and she hasn't heard any news from the patient since then.".

• 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: 21998762
• Report Number: 3014162263-2025-00022
• Device Sequence Number: 15657128
• Product Code: KRD
• UDI-Device Identifier: 00810068567632
• UDI-Public: (01)00810068567632(11)250122(17)300122(10)F250100769
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PRES0865CPKPLT
• Device Lot Number: F250100769
• 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: 04/09/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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