MAUDE Adverse Event Report: BALT USA PRESTIGE COIL SYSTEM

Model Number	PRES0156CXPPLT
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
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 f240300302 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 performing a fontan embolization using a 2.4 progreat microcatheter and the 1.5 x 6cm coil was about 80% out when it balled up in the distal tip.He pulled the microcatheter back into the 4f glidecath to have the coil unlodge but then prolapsed inside the 4f glidecath.After wire manipulation and pushing the coil finall popped out to travel into a side branch leaving a long tail.He finally coiled that branch and was able to jail the coil so it would not move.He said the coil got stuck in the micro and he should have flushed it out first before pulling the micro into the glidecath." update 15nov2024 - additional information received from the issuer: "patient is satisfactory and was discharged." 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 92604
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92604 ; 9497881443
• MDR Report Key: 20914344
• Report Number: 3014162263-2024-00097
• Device Sequence Number: 15415563
• Product Code: KRD
• UDI-Device Identifier: 00810068567328
• UDI-Public: (01)00810068567328(11)240308(17)290308(10)F240300302
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/12/2024

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: PRES0156CXPPLT
• Device Lot Number: F240300302
• 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: 11/12/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown