MAUDE Adverse Event Report: Balt USA Prestige Coil System

Model Number	PRES1655COM18
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "the coil was released inside the micro, and it had not yet been fully deployed.The physician did not make any movement or apply any force that could have caused the coil to be released on its own.Using a small amount of saline, the doctor pushed the portion that had remained inside the microcatheter.Since the embolization device was not in the correct position, the physician had to retrieve it using a snare due to the risk of migration.We need to determine the cause or reason why the coil was released inside the microcatheter without using the ultra detachment system." incident report form submitted for this complaint indicates that no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference #(b)(4).Pending return of device for analysis.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: 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 ; +1(949)788-1443
• MDR Report Key: 50116669
• Report Number: 3014162263-2026-00079
• Device Sequence Number: 17456221
• Product Code: KRD
• UDI-Device Identifier: 00840303708094
• UDI-Public: (01)00840303708094(11)250426(17)300426(10)F250401163
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K200030
• 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): 09/30/2026

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: PRES1655COM18
• Device Lot Number: F250401163
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2026
• Supplement Date Received by Manufacturer: 07/04/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2025
• 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; Required Intervention
• Patient Sex: Unknown