MAUDE Adverse Event Report: BALT USA PRESTIGE COIL SYSTEM

Model Number	PRES0320CXPPLT
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference: #(b)(4).Note: initial notification of the complaint received on 12aug2024.Reportability assessment was made based on the available information at that time, which determined that the event did not meet the reporting requirements.On 17sep2024 additional information was received from the issuer and following an additional assessment of the event with this additional information, the event was assessed to be reportable.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 f240300154 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: "we are still finding out information about the case but here is what is known: the physician was using a bsc renegade microcathter and a prestige plus coil got stuck inside the cathter.He was not able to remove the coil or advance so catheter was removed." update 17sep2024 - additional information received from the issuer: "1st case inferior mesenteric artery embolization microcatheter used was a boston scientific stc pres0320cxpplt lot#f240300154 the physician stated that he had to reposition the coil 4-5 times in order for proper placement.He did not feel any significant resistance however once he deployed the coil and upon removal of the stc catheter he noticed the thin filament coming out of the microcatheter.He had to magnify up to get a better visual and proceed to snare the coil for 2 hours until it was fully retrieved from the patient." 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: 20464784
• Report Number: 3014162263-2024-00083
• Device Sequence Number: 21024835
• Product Code: KRD
• UDI-Device Identifier: 00810068567410
• UDI-Public: (01)00810068567410(11)240306(17)290306(10)F240300154
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/16/2024

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: PRES0320CXPPLT
• Device Lot Number: F240300154
• 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: 09/17/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown