MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0620HST10
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "after inserting 15 coils, 6×20 was inserted last, but the coil loop came out of the neck.After pushing the coil in and out twice, the coil did not move.When checked it was found that it was pre-detached." 05jan2022 update - additional information received from issuer: "the second photo shows 6x20 was too long so the loop of the coil was rolled and pushed up.Two solitaire fr stents 6x30s from medtronic were deployed and coil was attached to vessel wall.After the final angio, there were no problems with the patient's condition.However, the operator, the neurosurgery clinic manager, recognized it as a serious defect.During pusher delivery there was no friction during the pre-detachment.When the coil was pulled back, it felt like the coil was not attached during the pre-detachment.".
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.Customer provided the following justification as to why there was a delay between incident date and the date balt usa was notified: "it was reported to us late from the hospital, and was reported to balt usa as soon as we received it." 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 f200500036 has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.

• 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: 13343079
• Report Number: 3014162263-2022-00001
• Device Sequence Number: 4164546
• Product Code: HCG
• UDI-Device Identifier: 00818053022487
• UDI-Public: 00818053022487
• 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): 01/19/2021

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: 05/11/2022
• Device Model Number: OPTI0620HST10
• Device Catalogue Number: N/A
• Device Lot Number: F200500036
• 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: 05/11/2020
• 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