MAUDE Adverse Event Report: BALT USA PRESTIGE COIL SYSTEM

Model Number	PRES0865HPKPL
Medical Device Problem Codes	Stretched (1601); Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
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 f230900729 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: "hi team, can you please replace the pres0865hpkpl to account.We had a coil break and stretch in a tortous splenic aneuyrsm.I will send pics of anatomy as well.Placed 3 coils prior to placing the 8x65 the coil.The coil was roughly 5cm into aneuyrsm doctor felt friction decided to pull back and resheath and coil broke and stretched.We spent 2.5 hours trying to retrieve coil was able to get all of filar out but had to leave a loose portion of coil in splenic.This is the 11th complaint of the year with this one account.I did 10-11 complaints in all of 2023, there seems to be on going issues with the prestige coils." update 07jun2024 - additional information received from the issuer: "1.Did the procedure involve tortuous anatomy? - anatomy was tortuous at site for emobization, the coil broke at proximal end as it was being introduced.2.Can you confirm if there were any attempts made to detach the implant coil using the detachment controller? no attempts to detach were made it simply broke and unraveled." incident report form submitted for this complaint indicates that no patient injury was sustained.Update 21jun2024 - additional information received from the issuer: "was the portion of the coil that was left behind left inside of the splenic aneurysm? per the picture i shared the distal 8-10cm.How did the physician attempt to retrieve the coil (snare, stent retriever, etc.)? he tried several times to snare the device.What is the patient's current condition? patient is ok".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.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 f230900729 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: "hi team, can you please replace the pres0865hpkpl to account.We had a coil break and stretch in a tortous splenic aneurysm.I will send pics of anatomy as well.Placed 3 coils prior to placing the 8x65 the coil.The coil was roughly 5cm into aneurysm doctor felt friction decided to pull back and resheath and coil broke and stretched.We spent 2.5 hours trying to retrieve coil was able to get all of filar out but had to leave a loose portion of coil in splenic.This is the 11th complaint of the year with this one account.I did 10-11 complaints in all of 2023, there seems to be on going issues with the prestige coils." update 07jun2024 - additional information received from the issuer: "1.Did the procedure involve tortuous anatomy? anatomy was tortuous at site for embolization, the coil broke at proximal end as it was being introduced.2.Can you confirm if there were any attempts made to detach the implant coil using the detachment controller? no attempts to detach were made it simply broke and unraveled." incident report form submitted for this complaint indicates that no patient injury was sustained.Update 21jun2024: additional information received from the issuer: "was the portion of the coil that was left behind left inside of the splenic aneurysm? per the picture i shared the distal 8-10cm.How did the physician attempt to retrieve the coil (snare, stent retriever, etc.)? he tried several times to snare the device.What is the patient's current condition? patient is ok." 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: 19680700
• Report Number: 3014162263-2024-00040
• Device Sequence Number: 3239409
• Product Code: KRD
• UDI-Device Identifier: 00810068567878
• UDI-Public: (01)00810068567878(11)230923(17)280923(10)F230900729
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 07/05/2024

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: PRES0865HPKPL
• Device Lot Number: F230900729
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2023
• 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: Required Intervention
• Patient Sex: Unknown