MAUDE Adverse Event Report: BALT USA, LLC BARRICADE COIL

Model Number	900068
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The barricade coil was successfully implanted; therefore it was not received for evaluation.Analysis could not be performed.Based on the available information, the root cause of this complaint may have been related to the incorrect selection of the coil size as well as the microcatheter being inserted too deep into the aneurysm.Review of the lot history records for the reported lot did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against the reported lot have been made for the same issue.
Event or Problem Description
It was reported that while treatment of an aneurysm located at mca."the tip of mc (echelon 10) was placed at middle of the aneurysm and the coil was push-out from the catheter.However, the first loop came off from the aneurysm, and microcatheter kicked-back to main vessel during withdrawal of the coil.Then, the surgeon re-inserted the microcatheter into the aneurysm deeper than first attempt and tried to push-out the coil into the aneurysm.When about 90% of the total length was placed, one of the loop was came off out of the aneurysm and then it was confirmed that the perforation was occurred.The surgeon performed reversing of heparin and inflating the balloon for the treatment for the perforation.Four minutes passed, the surgeon deflated the balloon and performed contrastradiography, it was confirmed that the bleeding was stopped.Finally, the coil had detached properly at reverse "t" position.The procedure was completed since there was no problem for the patient's situation (consciousness, speech, visual field etc.)" surgeon's comments: he commented that he mistook the selection of the coil size, he should not have been selected long coil.Also, he commented that the tip of microcatheter might have inserted too deep into the aneurysm.

• Brand Name: BARRICADE COIL
• Common Device Name: BARRICADE COIL
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• MDR Report Key: 7539551
• Report Number: 3009698517-2018-00007
• Device Sequence Number: 1898466
• Product Code: HCG
• UDI-Device Identifier: 00818053020124
• UDI-Public: 00818053020124
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 05/01/2022
• Device Model Number: 900068
• Device Catalogue Number: 900068
• Device Lot Number: 062217A-068
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/23/2018
• 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