MAUDE Adverse Event Report: BALT USA PRESTIGE COIL SYSTEM

Model Number	PRES1865CPKPLT
Medical Device Problem Codes	Stretched (1601); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
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 was deployed and upon removal of the pusher wire a string of coil came back with the pusher.He spent 2-3 hours snaring the broken coil from the patient with no harm." incident report form submitted for this complaint indicates that no patient injury was sustained.
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.The lot number was not provided therefore a review of the lot history records could not be performed.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.
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 f230900859 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 was deployed and upon removal of the pusher wire a string of coil came back with the pusher.He spent 2-3 hours snaring the broken coil from the patient with no harm.Update 17sep2024 - additional information received from the issuer: "2nd case portal vein embolization with extreme tortuosity.Microcatheter used was a boston scientific stc damaged coil pres1865cpkplt lot#f230900859.He advanced the coil into the abnormal venous shunt that was measuring around 15mm cross sectional.He stated that not all of the coil made it into the sac as he felt resistance.We did not determine how much of the 65cm made it into the sac but he decided to detach the coil and thought he would squirt the rest out.He had problems removing the pusher almost like it was "stuck" therefore he decided to remove the pusher with the microcatheter.As back out the microcatheter the coil elongated and followed eventually squirting out and staying in the vessel however not in the target zone.Was the catheter was out he removed the pusher and had to gain access again and finished the case with penumbra coils with no issue." 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: 20196273
• Report Number: 3014162263-2024-00072
• Device Sequence Number: 18053187
• Product Code: KRD
• UDI-Device Identifier: 00810068567793
• UDI-Public: (01)00810068567793(11)230927(17)280927(10)F230900859
• 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,Followup
• Report Date (Section B): 09/27/2024

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: PRES1865CPKPLT
• Device Lot Number: F230900859
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• 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; Required Intervention
• Patient Sex: Unknown