MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0407CSF10
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa's reference: # (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 f210900255 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: "the physician tried to embolize the optima coil into target lesion as first coil after deploying atlas stent.During placing implant coil, the physician found difficulty to operate its movement via pusher wire.Then the physician decided to withdraw the coil system and noticed that the coil got unraveled and fail of vessel.The coils had been retrieved by snare and the procedure was completed with competitive coil." 20may2022, additional information received from the issuer: "the coil did not get prematurely detached nor snapping apart.The reason why the physician used snare was it was difficult to retrieve distal part of coil by pulling pusher wire sine there was unraveled part between them.The most part of coil was remained aneurysm however were partly pulled our by attempt of retrieve.Where was the implant retrieved from with the snare? was the implant located in the microcatheter or outside of the microcatheter when it was retrieved? it was mainly from target lesion(aneurysm) and main vessel.How was the anatomy of the patient, was it tortuous? we have not heard there 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: 14639193
• Report Number: 3014162263-2022-00017
• Device Sequence Number: 12192576
• Product Code: HCG
• UDI-Device Identifier: 00818053026096
• UDI-Public: 00818053026096
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 05/27/2022

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: 09/13/2026
• Device Model Number: OPTI0407CSF10
• Device Catalogue Number: N/A
• Device Lot Number: F210900255
• 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: 05/18/2022
• Initial Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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