MAUDE Adverse Event Report: BALT USA BARRICADE COIL SYSTEM

Model Number	900100
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa's reference number:(b)(4).An evaluation of the actual complaint sample could not be performed as the device was unavailable for return.Based on the provided information, root cause could not be definitively determined.Lack of device return prevented deeper evaluation of the reported issue.Review of the lot history record for the reported lot was performed.Customer feedback has been noted for lot 011419c; however, there is no in-process or lot-specific issue that could account for the observation.This lot will remain 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.
Event or Problem Description
It was reported that: "the physician while treating a ruptured left anterior choroidal artery aneurysm, got access using 7fr long sheath and fargomax 105.Accessed the aneurysm with vasco 10 microcatheter and traxcess wire.Used eclipse 2l ballon as backup since the aneurysm is ruptured one.After accessing the aneurysm started deploying coils.Used 6 barricade coils of different sizes.After that took dsa and found that there is some more space to be filled for getting a complete occlusion of the aneurysm.So, the physician decided to use barricade helical finish 4 x 10 as the last coil.Without any issues the coil passed through the catheter into the aneurysm.After couple of loops (almost half of the length of the coil) while trying to push the coil, the physician noticed that the coil pusher wire is freely moving, but there is no movement to the coil.Physician slowly tried to pull back the pusher wire at that time too the wire is coming back freely with no interaction with the coil and confirmed that the coil got premature detachment within the micro catheter itself.After that physician slowly pulled back the micro.While doing that the entire coil mass was also moving and as few of the loops of the last coil got entangled with the earlier coils.Finally with great difficulty took out the micro, leaving the coil hanging in the parent vessel.Physician decided not to snare the hanging coil as it may pull back the whole coil mass and can occlude the parent artery completely.Patient was not extubated.But done imaging and found that there are minute infarcts.".

• Brand Name: BARRICADE COIL SYSTEM
• Common Device Name: BARRICADE
• Manufacturer (Section D): BALT USA; 29 parker
• MDR Report Key: 12128560
• Report Number: 3014162263-2021-00025
• Device Sequence Number: 11956308
• Product Code: HCG
• UDI-Device Identifier: 00818053020995
• UDI-Public: 00818053020995
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2021

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: 12/31/2023
• Device Model Number: 900100
• Device Catalogue Number: 900100
• Device Lot Number: 011419C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/07/2021
• 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; Required Intervention