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

Model Number	900070620FR10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To whom it may concern: balt usa is still waiting upon the return of the barricade coil.
Event or Problem Description
It was reported that: "dr (b)(6) (inr) decided to do a stent assisted coiling case of acom aneurysm with our coils.He used pconus device in this case.First two coils he deployed were barricade complex frame 11-7 and 8-27 and this was the third coil which he was deploying.It went well in the micro catheter but in side the aneurysm it was not behaving well so physician decided to reposition it.While taking out the coil from aneurysm, it got detached and almost more than half of the coil was outside the aneurysm.Further, he retrieved this coil with the help of snare and deployed microplex coils.He was surprised to see that without detachment how the coil can get detached.Finally he completed the procedure.".
Event or Problem Description
It was reported that: "dr.(b)(6) (inr) decided to do a stent assisted coiling case of acom aneurysm with our coils.He used pconus device in this case.First two coils he deployed were barricade complax frame 11-7 and 8-27 and this was the third coil which he was deploying.It went well in the micro catheter but in side the aneurysm it was not behaving well so physician decided to reposition it , while taking out the coil from aneurysm, it get detached and almost more then half of the coil was out side the aneurysm.Further, he retrieved this coil with the help of snare and deployed microplex coils.He was surprised to see that without detachment how the coil can get detached.Finally he completed the procedure.".
Additional Manufacturer Narrative
To whom it may concern: investigation confirmed that the implant had fully detached from the delivery system.The implant coil was stretched to wire and broken in two pieces, the most stretched damage appeared at the proximal end of the coil, the remainder distal end of the coil condition was intact.The delivery pusher was not returned for further evaluation.Based on the provided information the reported complaint and investigation finding.The possible root cause may be due to the tensile overload; however, without the ability to investigate the delivery pusher, there is insufficient information to conclusively determine the root cause.Detachment-related issues (including premature detachment) are well-understood failures for implantable coils.These types of failures are not infrequent nor unique to balt usa products, having an established history of occurrence across similar marketed devices for many years.Currently premature detachment on all lots is below threshold.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.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 121417a 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.

• Brand Name: BARRICADE COIL SYSTEM
• Common Device Name: BARRICADE COIL
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• MDR Report Key: 8753936
• Report Number: 3014162263-2019-00008
• Device Sequence Number: 16566692
• Product Code: HCG
• UDI-Device Identifier: 00818053020698
• UDI-Public: 00818053020698
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 07/02/2019

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: 12/14/2022
• Device Model Number: 900070620FR10
• Device Lot Number: 121417A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 07/18/2019
• 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