MAUDE Adverse Event Report: BALT USA BARRICADE COIL SYSTEM

Model Number	900001
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference #(b)(4).The returned device was inspected in our quality laboratory.During our analysis: we noted that the guidewire used during the incident was returned; we noted that the delivery pusher and introducer sheath were not returned - only the implant coil returned; we observed a minor kink and minor coil stretching 6.5cm distal of the implant's proximal end; we observed minor coil stretching 12cm distal of the implant's proximal end; we observed minor coil stretching 3cm and 4.5cm proximal of the implant's distal end; we observed the implant coil to be crushed 3.5cm proximal of the implant's distal end; we observed the sr thread to be protruding out of the implant's proximal end with the thread being opaque in color; we noted that further detachment testing could not be conducted due to unreturned delivery pusher.Root cause of the reported issues endured by the coil system cannot be definitively determined.Upon device return, the implant coil was observed to be damaged, with minor coil stretching throughout the coil.Additional analysis showed the sr thread to be protruding out of the implant's proximal end with the thread being opaque in color.This color of the sr thread indicates that the thread was slowly stretched until fracture, likely caused by tensile overload.It is unknown whether the implant coil was damaged during insertion into the microcatheter, or if the microcatheter was damaged during use.If the implant was damaged prior to insertion, this could have contributed to possible friction in the microcatheter, thereby leading to the reported premature separation.However, further analysis of the device could not be conducted due to the unreturned delivery pusher.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 f210500610 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: " sex/age: unknown.Location: m1 distal.Procedure: planned tae for unruptured aneurysm.Size of aneurysm: 5×5×5×2mm.Micro catheter: phenom17/medtronic (0.017inch). after placing 2 competitive coils and 2 barricade coils, during the third barricade coil insertion, the physician felt resistance to operate coil.Then the physician continued attempt with double catheter technique(another catheter was sl-10) (the physician repeat advancing and retrieving coil for three times).Then the physician noticed that the coil did not follow pusher wire no longer since the coil has been detached.Then they tried to retrieve the coil with snare, but it failed.The coil was pushed into distal side of parent artery.Although the physician considered to place stent, they finally finished procedure just confirming blood flow since there was the risk of pushing the coil into further distal of artery." 05jan2022 update - additional information received from issuer: "premature detachment of the implant occurred in the microcatheter, then the implant fell into the parent artery after the physician attempted to retrieve the implant with a snare.Then the procedure finished with no harm caused to the patient.Your understanding is correct.If my understanding is correct, can you confirm if the implant was removed? or was it left in the patient.It was left in the patient.".

• Brand Name: BARRICADE COIL SYSTEM
• Common Device Name: BARRICADE
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 13342917
• Report Number: 3014162263-2021-00046
• Device Sequence Number: 4064481
• Product Code: HCG
• UDI-Device Identifier: 00818053020025
• UDI-Public: 00818053020025
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/19/2022

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 Expiration Date: 04/30/2022
• Device Model Number: 900001
• Device Catalogue Number: 900001
• Device Lot Number: 051517B-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2017
• 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