MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI2265COM18
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference (b)(4).The returned device was inspected in our quality laboratory.During our analysis: we noted the associated introducer sheath and implant coil were not returned, only the delivery pusher; we observed minor damages at the detachment zone with the green lead wire bent; we observed no visual indications of a detachment cycle attempted at the detachment zone; we observed the sr thread to have a tapered tip at the break point, located just proximal of the detachment zone; we observed the sr thread to be slightly opaque in color; we observed 2 minor bends on the hypotube 13cm and 50cm distal of the gold connector; we observed a minor kink on the hypotube 40cm distal of the gold connector.Root cause of the premature detachment endured by the coil system can likely be attributed to an overload of tensile stress endured by the sr thread.Upon return of the delivery pusher, the detachment zone was observed to have a minor visual damage with the green lead wire bent.In addition, the sr thread was found to have a tapered tip at the break point just proximal of the detachment zone.In addition, the sr thread was found to have a slightly opaque color, indicating an overload of tensile stress was likely endured by the sr thread.It is mentioned in the description that the premature detachment of the implant coil was experienced during the repositioning of the coil.It is possible that the implant coil endured damages leading to the premature detachment during the repositioning of the implant coil in the treatment site.It was reported that no resistance was experienced during the advancement of the coil system, therefore it is unlikely that the implant coil sustained damage during the initial advancement of the coil system.It is unknown if the microcatheter associated with the incident was damaged, which could have caused friction during advancement attempts and potential lead to the reported premature separation.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 f200800040 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: "while embolize a dural fistula with our optima coil 22mm 65cm the coil was detached after 2 times repositioning in the venous pouch without using the detachment device - unfortunately the physician could not snare the coil, so the coil is in the venous vascular system which is uncritical, so the physician.The fistula is completely closed and the patient is fine." on 14apr2023, additional information provided by issuer - "there was no resistance.Advancement was smooth." incident report form received from the issuer indicated that no patient injury was sustained.

• 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: 16915475
• Report Number: 3014162263-2023-00015
• Device Sequence Number: 19396177
• Product Code: HCG
• UDI-Device Identifier: 00818053026553
• UDI-Public: 00818053026553
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/08/2023

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: 08/13/2025
• Device Model Number: OPTI2265COM18
• Device Catalogue Number: N/A
• Device Lot Number: F200800040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2020
• 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