MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0510HSS10
Medical Device Problem Codes	Fracture (1260); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 f201201187 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.
Event or Problem Description
It was reported that: "after non detachment of hss 5x10, during insertion of the same sized 5x10, it was pushed and pulled 2~3 times as it could not be inserted properly.When checked it was found that it was stretched, and solitaire stent retriever was used for partial retrieval of the stretched coil.The rest was attached to the vessel wall using a domestic intracranial stent." 29sep2022, additional information provided by issuer: " can you confirm that there was not harm/ injury sustained by the patient during/ post-procedure? what is the current status of the patient? there was no harm / injury sustained by the patient.Was the anatomy tortuous? we were informed the anatomy was tortuous.".
Additional Manufacturer Narrative
Balt usa reference #(b)(4).(follow up 3500a report submitted to correct the balt usa reference number - intial report indicated reference #(b)(4).Correct balt usa reference for this event is #(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 f201201187 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.
Event or Problem Description
It was reported that: "after non detachment of hss 5x10, during insertion of the same sized 5x10, it was pushed and pulled 2~3 times as it could not be inserted properly.When checked it was found that it was stretched, and solitaire stent retriever was used for partial retrieval of the stretched coil.The rest was attached to the vessel wall using a domestic intracranial stent.".29sep2022, additional information provided by issuer: "o can you confirm that there was not harm/ injury sustained by the patient during/ post-procedure? what is the current status of the patient? - there was no harm / injury sustained by the patient.O was the anatomy tortuous? - we were informed the anatomy was tortuous.".

• 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: 15565009
• Report Number: 3014162263-2022-00035
• Device Sequence Number: 20352910
• Product Code: HCG
• UDI-Device Identifier: 00818053026836
• UDI-Public: 00818053026836
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K172390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2022

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: 01/13/2026
• Device Model Number: OPTI0510HSS10
• Device Catalogue Number: N/A
• Device Lot Number: F201201187
• 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: 09/27/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• 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