MAUDE Adverse Event Report: BALT USA PRESTIGE COIL SYSTEM

Model Number	PRES0204CXPPLT
Medical Device Problem Codes	Failure to Advance (2524); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference: #(b)(4).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 f251000255 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: "the physician was doing a distal splenic embolization at around 1am.She mentions that the anatomy to get to the bleed was quite tortuous.She was using a 2.0fr progreat microcatheter.She had already used several prestige coils up to this point with no issue.The current product sku incident has nothing to do with the coil implant itself but the pusher.She deployed this 2mm x 4cm prestige plus coil in the last vessel and when she went to remove the pusher delivery system from the microcatheter she met a little resistance followed by no resistance at all, thinking that everything was ok.She tried to flush the microcatheter with saline, she noticed that there was heavy resistance trying to flush it, thinking that maybe the coil may not have been fully deployed.She then looked did a live fluoro shot (no contrast) to confirm that the coil was fully removed.She tried a second time to flush the microcatheter with saline, using a bit more force and felt the microcatheter clear out.The physician then decided to do one more post embolization contrast run and noticed what looked to be the distal part of the pusher delivery system.She notes that the radiopaque marker that is set back 3cm from the coil is in the vessel followed by a radiolucent string.According to the physician, patient is doing ok.Unfortunately, the staff trashed the faulty pusher delivery system because they originally had assumed that the coil deployed properly and that there wasn't an issue." incident report form submitted for this complaint indicates that no patient injury was sustained.

• 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: 25262096
• Report Number: 3014162263-2026-00062
• Device Sequence Number: 5495932
• Product Code: KRD
• UDI-Device Identifier: 00810068567342
• UDI-Public: (01)00810068567342(11)251009(17)301009(10)F251000255
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/22/2026

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: PRES0204CXPPLT
• Device Lot Number: F251000255
• 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: 04/24/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2025
• 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