MAUDE Adverse Event Report: BALT USA PRESTIGE COIL SYSTEM

Model Number	PRES0202CXPPL
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "pres02020cxppl, lot: f231100619 was advanced into the vessel.It was determined coil was slightly oversized and physician chose to go with a 1mm coil.Upon pulling the coil back to remove it, the coil detached." update 10dec2024: additional information received from the issuer: "the detachment occurred when the coil was half in the vessel and half in the microcatheter roughly.They had to pull the microcatheter out under negative pressure with a syringe.When they reassessed the treatment vessel, they switched over to penumbra coils." incident report form submitted for this complaint indicates that no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference#: (b)(4).The returned device was inspected in our quality laboratory.During our analysis: we noted the implant coil was received, however the delivery pusher, introducer sheath, and microcatheter were not returned.We observed the implant coil was broken.Approximately,.6mm distal tip of the implant coil.We observed the sr thread of the implant coil to be opaque in color.Root cause of the reported issue cannot definitively be determined due to the incomplete device return.Upon return of the device, we observed the implant coil broken.It is unknown exactly what led to the reported issue based on the limited device analysis that was able to be performed.If the microcatheter were to have become damaged or ovalized, this could have resulted in the implant coil encountering friction and further leading to the premature detachment.Without the delivery pusher, introducer sheath and microcatheter returned, further analysis and testing could not be performed.A review of the lhr indicated that the unit was free from visual damage, including the implant coil at the point of the 100% final inspection.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: f231100619 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 11/26/2024, 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 12/10/2024, 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.

• 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: 21113418
• Report Number: 3014162263-2024-00105
• Device Sequence Number: 12682473
• Product Code: KRD
• UDI-Device Identifier: 00818053027307
• UDI-Public: (01)00818053027307(11)221207(17)271207(10)F231100619
• 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
• 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): 01/09/2025

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: PRES0202CXPPL
• Device Lot Number: F231100619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• 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