MAUDE Adverse Event Report: BALT USA BARRICADE COIL SYSTEM

Model Number	9000680413FR10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To whom it may concern: currently pending on device return.
Event or Problem Description
It was reported that: "at performing a medical procedure of intracranial endovascular therapy for a brain aneurysm which was broken, the coil barricade 4x13 deployed by itself.If stretched and got thin.So, the deployed part stayed in the aneurysm and carotid.The part of the stent which was possible to recover was sent back to the distributor so that they ask the manufacturer for the regarding analysis.After the incident a stent was implanted in order to fix the coil which stayed in the carotid.".
Event or Problem Description
At performing a medical procedure of intracranial endovascular therapy for a brain aneurysm which was broken, the coil barricade 4x13 deployed by itself.If stretched and got thin.So, the deployed part stayed in the aneurysm and carotid.The part of the stent which was possible to recover was sent back to the distributor so that they ask the manufacturer for the regarding analysis.After the incident a stent was implanted in order to fix the coil which stayed in the carotid.Follow up sent (8/23/2019): "did the device detach before or after a detachment cycle was initiated?.It stated that part of the coil stayed in the aneurysm.Did the coil break? why was this reported to invima? was it reported by the hospital or by c.I.Dismecol? what occurred with the stent?" follow up received (8/30/2019): " it was before a detachment cycle was initiated.Yes, the coil broke it was reported to invima by the institution because according to their protocols they had to.It was the pharmaceutical chemist's decision.The coil stayed pressed to the artery's wall.That's why it was necessary to use a stent in order to avoid it to stay floating and that it might migrate." follow up sent (9/4/2019): "are there any further country-specific requirements for following up on the event, given that a report was sent to the invima by the user?" follow up received (9/4/2019): "not really.The normal procedure is that once the hospital has reported the case to invima they (invima) send us a requirement to give reply to that open case and once the manufacturer provides the technical analysis we as distributor submit it to them and finally they close the case but there is not a deadline specified to do it so.Regarding this case up to now the invima hasn't opened the follow up case.By the way, i haven't sent this item to you for the analysis due there was another incident with another coil so i expect to receive it tomorrow with the report so that i can make only one shipment with both products on friday.".
Additional Manufacturer Narrative
Based upon the state of the returned stretched resistance thread, the stretched coil complaint can be confirmed.Root cause is unknown, due to limited investigation of the returned materials and reported event details.Unable to confirm premature detachment, although stretching of the implant leading to tensile overload is a known cause for this failure type.Customer did not report if other devices were placed in proximity to the treatment site.Interaction with other devices leading to unintentional snaring or entanglement is a known potential root cause for both stretching and premature detachment.Insufficient information provided to determine if this was a factor.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.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; 29 parker; irvine CA 92618
• MDR Report Key: 9099062
• Report Number: 3014162263-2019-00015
• Device Sequence Number: 11438007
• Product Code: HCG
• UDI-Device Identifier: 00818053020674
• UDI-Public: 00818053020674
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K151760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2019

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: 08/18/2022
• Device Model Number: 9000680413FR10
• Device Lot Number: 081817A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 10/19/2019
• 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: Other