MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0308CSS10
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
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.No additional complaints against lot number f210600283 has been made for the same issue.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: "after inserting the coil, the shape and location were unsatisfactory, so recapture was tried twice.When recapture was tried again, the coil did not move.When checked it was found that it was pre-detached." 05jan2022 update - additional information received from issuer: "during deployment of the complex super soft 3x8 coil, the loop kept coming out of the aneurysm.The microcatheter was inserted in and out 3 times.The coil did not move, and when checked, it was found to be pre-detached.The coil was left inside the microcatheter.The pusher wire of the coil was used to push the coil that was inside the microcatheter into the aneurysm.The coil remaining in the microcatheter was inserted into the aneurysm as much as possible, but the proximal part of the coil could no longer be inserted, so the same stent was deployed in the coil assistant stent (stryker atlas) that was previously deployed in the parent artery so that the coil loop does not injure the artery and procedure was finished.The final angio photo after the surgery shows the patient had no serious injuries.".

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 13343169
• Report Number: 3014162263-2022-00002
• Device Sequence Number: 11803292
• Product Code: HCG
• UDI-Device Identifier: 00818053025891
• UDI-Public: 00818053025891
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K172390
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2022

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: 06/15/2026
• Device Model Number: OPTI0308CSS10
• Device Catalogue Number: N/A
• Device Lot Number: F210600283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown