MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM; BARRICADE COIL

Model Number	OPTI0206CSS10
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation of the actual complaint sample could not be performed as device was reported unavailable.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 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.
Event or Problem Description
The physician was coiling a 3mm peri-opthalmic aneurysm.He placed a 2.5x17 lvis and framed with 3x6 css.He then placed a 3x4 css.On the 3rd coil, a 2x6 css was introduced with the microcatheter position still at the dome of the aneurysm.The 2nd loop herniated out of the dome and angiographically appeared to perforate the aneurysm.The fellow pushing the coil had (b)(6) take over where he moved the mc position and manipulated the coil back into the aneurysm.He detached the coil.Post angio showed contrast in the sub a space and he reversed her heparin with protamine.He then went into the ica with a scepter balloon and kept it up for short periods of time.Post balloon/protamine showed no more contrast leakage, and he ended the case.The patient woke post anesthesia without any neuro deficits.(b)(6) thought it was the jailed microcatheter position that caused the perforation.

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: BARRICADE COIL
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• MDR Report Key: 9273223
• Report Number: 3014162263-2019-00017
• Device Sequence Number: 2695090
• Product Code: HCG
• UDI-Device Identifier: 00818053020674
• UDI-Public: 00818053020674
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K172390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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: 08/06/2022
• Device Model Number: OPTI0206CSS10
• Device Catalogue Number: N/A
• Device Lot Number: 080619A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2019
• 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