MAUDE Adverse Event Report: BALT USA PRESTIGE COIL SYSTEM

Model Number	PRES0750HPKPL
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
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 f230500320 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 initial notification of this event was received on 11/12/2024, for which the event details were assessed and determined the event did not meet any regulatory reporting requirements.Additional information received from the issuer regarding the case on 12/02/2024, for which the complaint file was re-assessed for reportability and concluded that based on the additional information received, this complaint file will be updated to a reportable event.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: "pres0750hpkpl was deployed into a splenic artery and would not detach.10 plus attempts were made and second detachment handle to no avail.The coil was retracted.During the coil being removed it prematurely detached and snapped half way down the implant.The rest of the coil in the microcatheter was attempted to be pushed in with a coil pusher and was ultimately flushed in to finish the case." update 02dec2024 - additional information received from the issuer: "1) was any of the implant protruding out of the mc when the detachment happened? yes, the coil was being retracted and was half in the mc and half in the vessel when the detachment happened.2) was any additional devices used in order to move/retrieve the implant coil? yes, they did open a coil pusher to try to push the coil the rest of the way in, however it didn't work and that is why the chose to flush the coil in.3) was there any impact to the patient following the implant coil being flushed into the treatment location? yes, the embolization was off target.Luckily, it was not in the parent vessel, so in this case a slightly off target embolization was still acceptable." 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: 21027267
• Report Number: 3014162263-2024-00104
• Device Sequence Number: 8310715
• Product Code: KRD
• UDI-Device Identifier: 00810068567861
• UDI-Public: (01)00810068567861(11)230508(17)280508(10)F230500320
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/27/2024

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: PRES0750HPKPL
• Device Lot Number: F230500320
• 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: 12/02/2024
• Initial Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2023
• 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