MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0102HSSMX
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "right pca aneurysm radial access with wrist catheter and sl 10 micro.The aneurysm was distal pca near bifurcation, it was a recanalization.The physician treated the aneurysm with balt coils and it was going well.The final coil was going in and the physician was happy with the coil placement and went to detach and the coil would not detach.The physician tried to advance the coil further out of the micro and manipulated the coil back and forth several times and the previous coil of the same size was dislodged and went into the proximal p2.The doc pulled the coil out and was very unhappy and went in with a micro wire and sl10 to push the coil further distal in the p2.The doc said he could not retrieve it and ended the case there." incident report form submitted for this complaint indicates that no patient injury was sustained.24oct2023, additional information provided by issuer - "the patient is doing well to my understanding.".
Additional Manufacturer Narrative
Balt usa reference #(b)(4).The returned device was inspected in our quality laboratory.During our analysis: we observed the introducer sheath was not included with the device return; we observed the multiple minor kinks along the implant coil; we observed no damages to the detachment zone with the pet jacket, lead wire, solder joints and sr thread intact; we observed multiple minor kinks along the hypotube; we tested for the performance characteristics and noted the electrical resistance to be out of specification; the delivery pusher was cut at the body coil to isolate the electrical resistance measurements; we noted an electrical resistance on the delivery pusher's proximal side to be abnormal; we noted an electrical resistance on the delivery pusher's distal side to be normal; root cause of the detachment failure endured by the coil system can be attributed to internal damage sustained by the proximal side of the delivery pusher.Upon device return, we observed the multiple minor kinks along the implant coil.To further investigate, the coil system was tested with two xcel detachment controllers; the controllers displayed flashing red/green lights.Performance characteristics of the delivery pusher were then tested using a multimeter, yielding an electrical resistance which measured to be out of specification.The delivery pusher was cut in half to isolate electrical resistance measurements of both halves of the delivery pusher.The delivery pusher's proximal end was noted to have an abnormal electrical reading.The lhr indicates that the electrical resistance of the coil system was within specification at the time of final inspection.In addition, it is reported the implant coil was attempted to be repositioned in the treatment site multiple times, likely contributing to the reported detachment issues and the migration of the previously placed implant coil in the treatment site.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 f220800049 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.

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 18193328
• Report Number: 3014162263-2023-00071
• Device Sequence Number: 18080841
• Product Code: HCG
• UDI-Device Identifier: 00818053025396
• UDI-Public: 00818053025396
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200030
• 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): 11/21/2023

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 Model Number: OPTI0102HSSMX
• Device Lot Number: F220800049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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