MAUDE Adverse Event Report: Balt USA Prestige Coil System

Model Number	PRES2265COM18
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "during the procedure to place an endoprosthesis for a right common iliac artery aneurysm, the aneurysm was visualized via arteriography.Selective cannulation of the right iliac artery was performed using a guidewire; the catheter was not advanced further.Vert, internal mammary, and simmons 1 catheters were used.Puncture of the left common femoral artery was performed, followed by placement of a simmons catheter and cannulation of the contralateral right common iliac artery, without advancing the catheter into the right internal iliac artery.The 5fr sheath in the right common femoral artery was exchanged for a long sentran sheath.Two guidewires were passed through the sentran sheath: a lunderquist wire into the aorta and a hydrophilic wire into the aneurysm.A 5fr catheter was placed over the hydrophilic wire, and a micro-guidewire and microcatheter were introduced through the 5fr catheter.A medtronic endoprosthesis was deployed, and the aneurysm was excluded.A coil was passed through the microcatheter; however, it was damaged and broke inside the catheter.The microcatheter was withdrawn, and an attempt was made to advance the coil using a saline flush, but this was unsuccessful.The 5fr catheter and sentran sheath were removed.The coil was retrieved via the arteriotomy.Arteriorrhaphy was performed using 5-0 prolene suture.Closure and compression were maintained for 20 minutes." incident report form submitted for this complaint indicates that no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference: (b)(4).Investigation pending return of suspected device.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: 50105322
• Report Number: 3014162263-2026-00085
• Device Sequence Number: 13274659
• Product Code: KRD
• UDI-Device Identifier: 00840303708124
• UDI-Public: (01)00840303708124(11)251107(17)301107(10)F251100279
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: PRES2265COM18
• Device Lot Number: F251100279
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2026
• Supplement Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2025
• 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