MAUDE Adverse Event Report: BALT USA, LLC BARRICADE COIL SYSTEM

Model Number	9001050202CF10
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Codes	Aneurysm (1708); Patient Problem/Medical Problem (2688)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To whom it may concern: on february 15, 2019, we received a complaint regarding the use of a single barricade coil (2mm x 2cm complex finish coil)."it was planned as balloon assisted procedure for ic-pc recanalization.After placing 11th coil, the physicians decide to switch to stent assisted technique.The balloon was retreated, and the stent was placed through sl10 using jail technique.Then, the physicians started to use barricade coils for finishing.When the physician was to reposition 16th coil, feeling of pusher wire was missed.The coil was unraveled, and he could not withdraw the coils through the pusher wire.Using prowler select plus and goose neck snare, the physician could retreat coil with sl10.There was remained part of unraveled coil out of aneurysm, but it was in the stent.So, they decided to finish procedure.According to the physicians, it was procedure for recanalization and stent assisted.Perhaps the coil interfered with stent or other coils." the results of our investigation following return of the affected device, are summarized as follows: visual analysis revealed the delivery pusher with the introducer removed and the proximal end of the implant coil attached.Proximal to the detachment zone section the implant coil was completely stretched and unraveled, curling or pig tail on pusher wire was observed at the damaged zone.Implant was most likely snagged or caught with another coil when pulling back, which caused the coil to stretch and break.It is highly probable that the damage came as the result of significant strain, applied during placement or manipulation of the device once introduced.The condition of the returned device did however clearly denote that a break following excessive force took place, causing the coil to wedge inside the stent during retrieval.Based on the available information along with the investigation results, the reported complaint was confirmed as the attachment section is damaged.It is highly probable that the root cause of the damage came as the result of significant strain, applied during manipulation.Review of the lot history records for the reported lots did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number 062217a have been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.
Event or Problem Description
It was reported that: it was planned as balloon assisted procedure for ic-pc recanalization.After placing 11th coil, the physicians decide to switch to stent assisted technique.The balloon was retreated, and the stent was placed through sl10 using jail technique.Then, the physicians started to use barricade coils for finishing.When the physician was to reposition 16th coil, feeling of pusher wire was missed.The coil was unraveled, and he could not withdraw the coils through the pusher wire.Using prowler select plus and goose neck snare, the physician could retreat coil with sl10.There was remained part of unraveled coil out of aneurysm, but it was in the stent.So, they decided to finish procedure.According to the physicians, it was procedure for recanalization and stent assisted.Perhaps the coil interfered with stent or other coils.".

• Brand Name: BARRICADE COIL SYSTEM
• Common Device Name: BARRICADE COIL
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• MDR Report Key: 8400641
• Report Number: 3014162263-2019-00001
• Device Sequence Number: 312368
• Product Code: HCG
• UDI-Device Identifier: 00818053021046
• UDI-Public: 00818053021046
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2019

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: 06/22/2019
• Device Model Number: 9001050202CF10
• Device Lot Number: 062217A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/07/2019
• 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