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

Model Number	900106
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664)
Health Effect - Clinical Codes	Aneurysm (1708); Patient Problem/Medical Problem (2688)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The visual analysis revealed the implant coil separated from the delivery pusher.The coil was not returned for evaluation.By the appearance of the detachment zone it shows that the coil could have been snagged/caught in the stent while retrieving.Once a loop(s) was snagged, the rest of the coil will stretch leading to breakage.Analysis determined that the reported stretching could have been caused by the complications inherent to deployment in the proximity of other previously-placed neurovascular devices.Previous testing has demonstrated that the overall risk of tensile overload and coil stretching increases under these circumstances.It has been concluded that this was likely the root cause.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 the reported lot number have been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.At this time, no such increase in rate of occurrence has been.
Event or Problem Description
It was reported that: "the surgeon tried to place 2mm x 3cm complex finish coil into the an but the coil has unraveled due to the tip of sl-10 dropped off from the an.Then unraveled coil(primary coil) moved to siphon region by blood flow.Therefore, a stent (4.5 x 3 neuroform atlas / stryker) was placed siphon region to lock unraveled coil and the pusher wire was removed, however a part of coil tail remains within the patient.Surgeon's comments: he commented that this case might had been occurred due to the coil catching on strut of the stent.".
Event or Problem Description
It was reported that: "the surgeon tried to place 2mm x 3cm complex finish coil into the an but the coil has unraveled due to the tip of sl-10 dropped off from the an.Then unraveled coil(primary coil) moved to siphon region by blood flow.Therefore, a stent (4.5 x 3 neuroform atlas / stryker) was placed siphon region to lock unraveled coil and the pusher wire was removed, however a part of coil tail remains within the patient.Surgeon's comments: he commented that this case might had been occurred due to the coil catching on strut of the stent.".
Additional Manufacturer Narrative
Follow up: device was not explanted.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.Attachment: [1525.Pdf].

• Brand Name: BARRICADE
• Common Device Name: BARRICADE COIL
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• MDR Report Key: 7862107
• Report Number: 3009698517-2018-00011
• Device Sequence Number: 11124173
• Product Code: HCG
• UDI-Device Identifier: 00818053021053
• UDI-Public: 00818053021053
• 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 Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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: No Information
• Device Expiration Date: 05/02/2022
• Device Model Number: 900106
• Device Catalogue Number: 900106
• Device Lot Number: 050217A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 09/10/2018
• 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