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	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The visual analysis revealed the implant coil attached to the delivery pusher.The implant coil was stretched and broken in two pieces.The broken distal portion of the implant coil was received inside of the returned "y" connector, with the stretched coil protruding at both ends.The "y" connector was tight enough not allowing the coil to be removed.From the information provided it appears that the coil started to stretch during retraction.Once in the "y" connector and during manipulation the coil possibly bunched up with the tightness of the connector.When the coil was pulled back it exceeded tensile, leading to the coil to stretch.Subsequently leaving the distal portion of the coil protruding out of the "y" connector.Based on the provided information, the possible root cause of this complaint cannot be determined; however, the condition of the returned device is consistent with the coil being exposed to a force that exceeded the maximum tensile specification.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 have been made for the same issue.
Event or Problem Description
It was reported that: "4th coil (2mm x 3cm complex finish coil) was stretched (unraveled).The microcatheter was dropped off from the an unintentionally during insertion of the coil and remaining 5mm coil could not be placed.The surgeon tried to re-insert the microcatheter into the an but it could not be successful.So, whole coil system was removed from the patient.Surgeon's comments: the surgeon commented that the selection of long coil (3cm) was not properly for this case.Unravel of coil might have due to operation of microcatheter during re-insertion.".
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: [1524.Pdf].
Event or Problem Description
It was reported that: "4th coil (2mm x 3cm complex finish coil) was stretched (unraveled).The microcatheter was dropped off from the an unintentionally during insertion of the coil and remaining 5mm coil could not be placed.The surgeon tried to re-insert the microcatheter into the an but it could not be successful.So, whole coil system was removed from the patient.Surgeon's comments: the surgeon commented that the selection of long coil (3cm) was not properly for this case.Unravel of coil might have due to operation of microcatheter during re-insertion.".

• Brand Name: BARRICADE
• Common Device Name: BARRICADE COIL
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• MDR Report Key: 7862104
• Report Number: 3009698517-2018-00010
• Device Sequence Number: 1940989
• 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: 04/30/2023
• Device Model Number: 900106
• Device Catalogue Number: 900106
• Device Lot Number: 043018A
• 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