MAUDE Adverse Event Report: BALT USA PRESTIGE COIL SYSTEM

Model Number	PRES0320CXPPLT
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "dr.(b)(6) was performing a y90 treatment.Under fluoroscopic imaging there were vessels distal to the treatment segment that he wanted to coil to prevent non target embolization.He decided to use a 3mm x 20cm prestige plus complex coil.Angiography showed normal anatomy.He used a 2.4fr terumo progreat mc to get to where he wanted.He inserted the coil into the mc with no resistance in delivering the coil through the mc.As the coil was getting to the desired area and about à of the coil was out of the tip of the mc, dr.(b)(6) had gently pulled back to adjust his coil.This is where the coil predetached from the pusher delivery system.Dr.(b)(6) then had to "push" out the coil by injecting saline solution through a syringe.The coil was implanted, however it blocked (jailed off) the vessel that he wanted to target for chemo therapy." incident report form submitted for this event indicated no patient injury was sustained as a result of this incident.
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 f230800240 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.

• 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: 18165453
• Report Number: 3014162263-2023-00070
• Device Sequence Number: 6503578
• Product Code: KRD
• UDI-Device Identifier: 00810068567410
• UDI-Public: 00810068567410
• 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
• Device Implanted Year: 2023
• 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): 11/16/2023

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
• Device Model Number: PRES0320CXPPLT
• Device Lot Number: F230800240
• 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: 10/20/2023
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2023
• 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