MAUDE Adverse Event Report: BALT USA BARRICADE COIL SYSTEM

Model Number	900106
Medical Device Problem Codes	Device Slipped (1584); Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
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 records did not reveal any in-process or lot-specific issue that could account for the observation.One additional complaint against lot number 012519b has been made for premature detachment.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.
Event or Problem Description
It was reported that: "the case was an acom anuerysm measuring 3mmx2.5mm and having a neck of 2.3 mm.Since it was a ruptured anuerysm the physician planned to do a balloon assisted coiling.The support hardware was neuromax ,fargomax 6f, eclispe 6x9 ,vasco 10 mp with hybrid 12/14 guide wire.The first coil was complex finish 3mmx4mm.The coil was deployed with balloon inflation and the second coil was complex finish 2mmx3mm and when half a cm of coil was remaining to be pushed,the micro was out of the anuerysm.The physcian wanted to withdraw the coil in order to reposition the micro with wire and when he was attempting to withdraw the coil it had prematurely detached (note:- no manupilation was done to push the micro with the coil support).No movement of coil was observed on withdrawl of the push wire the coil had come out half streched ,the physcian used the hybrid 12/14 through the vasco 10 to ensure no coil was still present in the micro with the eclipse inflated but during this process some part of the coil came into the aca.The micro and balloon was removed.The physcian used xt 27 and solitaire 4x20,captured the coil & removed it.Post removal of the streched coil ,the physcian completed the procedure by using barricade helical finish 1.5x4.The patient being covid 19 positive due to sterility concerns they had to discard all the hardware and they couldnt give the pushwire for evaluation.But a cd has been provided for the refrence.Follow up - patient is stable and responding no defecits.".

• Brand Name: BARRICADE COIL SYSTEM
• Common Device Name: BARRICADE
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• MDR Report Key: 11334011
• Report Number: 3014162263-2021-00002
• Device Sequence Number: 16998270
• Product Code: HCG
• UDI-Device Identifier: 00818053021053
• UDI-Public: 00818053021053
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

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: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 900106
• Device Catalogue Number: 900106
• Device Lot Number: 012519B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/16/2021
• 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: Required Intervention