MAUDE Adverse Event Report: BALT USA BARRICADE COIL SYSTEM

Model Number	900104
Medical Device Problem Codes	Device Slipped (1584); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa's reference number: (b)(4).Analysis pending on the device return.
Event or Problem Description
It was reported that: "in the treatment of an aneurysm's bifurcation on a female patient (b)(6), after three attempts the coil did not deploy so it was decided to retrieve it but it broke leaving a part of it in the vessel, then it was pushed with another coil but the previous one had left occlusion in part of the artery because there was no control on the broken coil.Despite a branch of the vessel was occluded it was not reported that the patient had significant injury.".
Event or Problem Description
It was reported that: "in the treatment of an aneurysm's bifurcation on a female patient aged 60, after three attempts the coil did not deploy so it was decided to retrieve it but it broke leaving a part of it in the vessel, then it was pushed with another coil but the previous one had left occlusion in part of the artery because there was no control on the broken coil.Despite a branch of the vessel was occluded it was not reported that the patient had significant injury.".
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.No additional complaints against lot number f200600296 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
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• MDR Report Key: 11171849
• Report Number: 3014162263-2020-00042
• Device Sequence Number: 16854336
• Product Code: HCG
• UDI-Device Identifier: 00818053021039
• UDI-Public: 00818053021039
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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: 06/20/2025
• Device Model Number: 900104
• Device Catalogue Number: 900104
• Device Lot Number: F200600296
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/09/2021
• 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