MAUDE Adverse Event Report: BALT USA BARRICADE COIL SYSTEM

Model Number	900111
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa's reference number: (b)(4).Analysis pending on the return of device.
Event or Problem Description
It was reported that: "procedure - coiling pathology - aneurysm associated products -fargo mini,vasco10,catch 4*20,vasco21d,hybrid,barricade,axs catalyst.A bilobed acom aneurysm was planned for treatment by simple coiling.7f/80cm arrow long sheath was parked in the left common carotid artery.Fargo mini was parked into petrous segment of left ica.Vasco10mp was navigated over hybrid 12 wire to the aneurysm.Barricade 6/20 complex frame coil was deployed first and detached.Barricade 2.5/4 complex finish coil was deployed in the aneurysm.Multiple attempts were made to detach this coil but coil didn't detach.So the operator decided to withdraw the coil however the coil detached prematurely and migrated in distal aca.Later this coil was retrieved by using catch 4/20.After this coiling was completed and case was uneventful".
Additional Manufacturer Narrative
Balt usa's reference number: (b)(4).The returned device was inspected in our quality laboratory.During our analysis: we observed the introducer sheath to not be returned with the delivery pusher and implant; we observed the implant to be completely stretched and knotted, with the first 3cm from the distal tip of the implant being unstretched; we noted the detachment zone shows visual signs of a detachment cycle being ran; we observed the proximal end of the implant to be fractured from delivery pusher; we observed two bends in the delivery pusher, one approximately 34cm distal of the detachment zone and one near the proximal end of the delivery pusher.Root cause of the unexpected detachment of the implant cannot definitively be determined.During our investigation, we observed the implant to be severely stretched and knotted.At the detachment zone, the delivery pusher showed signs of a detachment cycle being ran, but the proximal end of the implant appeared to be fractured from the delivery pusher.This aligns with the incident description of how multiple attempts were made to detach the implant, but the implant still did not detach.It is likely that the implant became caught on a secondary device at the treatment site, and while attempting to remove the coil system, the implant broke off of the delivery pusher.Although there were two bends in the delivery pusher, it is not likely that this affected the failed detachment due to their minor severity.These bends were likely caused from the user removing the coil system.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 f200500229 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: "procedure: coiling.Pathology: aneurysm.Associated products: fargo mini, vasco10, catch 4*20, vasco21d, hybrid, barricade, axs catalyst.A bilobed acom aneurysm was planned for treatment by simple coiling.7f/80cm arrow long sheath was parked in the left common carotid artery.Fargo mini was parked into petrous segment of left ica.Vasco10mp was navigated over hybrid 12 wire to the aneurysm.Barricade 6/20 complex frame coil was deployed first and detached.Barricade 2.5/4 complex finish coil was deployed in the aneurysm.Multiple attempts were made to detach this coil but coil didn't detach.So the operator decided to withdraw the coil however the coil detached prematurely and migrated in distal aca.Later this coil was retrieved by using catch 4/20.After this coiling was completed and case was uneventful.".

• Brand Name: BARRICADE COIL SYSTEM
• Common Device Name: BARRICADE
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• MDR Report Key: 11362967
• Report Number: 3014162263-2021-00005
• Device Sequence Number: 19778645
• Product Code: HCG
• UDI-Device Identifier: 00818053021107
• UDI-Public: 00818053021107
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

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: 06/15/2025
• Device Model Number: 900111
• Device Catalogue Number: 900111
• Device Lot Number: F200500229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention