MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0308CSS10
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
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 observed the complete coil system was included with the device return; - we noted the associated microcatheter was not returned; - we observed the implant coil to be severely stretched and still connected to the delivery pusher; - we observed the sr thread within the implant coil to be opaque in color - indicating the thread endured an overload in tensile stress; - we observed no damage to the detachment zone with the pet jacket, lead wire and solder joints intact; - we observed a minor kink along the hypotube, approximately 14.5cm proximal from the detachment zone; - we observed minor kinks along the hypotube, approximately 10cm, 24cm and 29cm distal from the first warning stripe; - we observed a major kink along the hypotube, approximately 15cm distal from the gold connector.Root cause of the reported issue can likely be attributed to an overload of tensile stress endured by the implant coil, however the entirety of the implant remained connected to the delivery pusher.Upon return of the device, we observed the implant coil to be severely stretched and still connected to the delivery pusher, indicating that the implant was not prematurely detached.In addition, we did observe the sr thread within the implant coil to be broken while be opaque in color, indicating the thread broke due to an overload in tensile stress.Further damage consisting of major and minor kinks along the hypotube were also identified along the returned coil system.It was reported the coil was prepped per the dfu and advanced through catheter without issue, however, the coil did not sit as needed and upon repositioning, it prematurely detached.As a result, it is likely the reported issue encountered by the user were due to the damages endured during the procedure since it was reported the coil system was prepared per the ifu.It's possible the coil system was damaged during advancement attempts leading to the kinks observed.Once the coil was repositioned, it is likely that the implant coil encountered additional resistance leading to an overload of tensile stress exerted on the implant coil, further causing the implant coil to stretch.Moreover, it is unknown if the microcatheter associated with the incident was damaged, which could have caused friction during advancement attempts and potentially lead to the reported premature separation.It is indicated in the lhr that the unit underwent 100% inspection which verifies that the implant was free of damage at the point of final inspection.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 f220601071 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: "the physician had a premature detachment of an optima 3mm x 8cm.Using an sl-10 95 degree microcatheter, the physician deployed 2 coils into a 6mm pcom aneurysm (one 6x15cm orbit and one 5x10cm optima css).For the 3rd coil, the physician prepped our 3x8 css per dfu and advanced through catheter without issue.Since the coil did not sit as he needed, the physician tried repositioning the 3x8 optima css and upon repositioning, it prematurely detached.He fortunately had enough of the coil in the microcatheter that allowed him to safely pull the microcatheter out of the body.As they pulled the microcatheter out, a small loop of the prevoius coil herniated out of the aneurysm.They felt confident that this small loop would not pose a safety risk.The concluded the case with a total of just two coils implanted.No patient injury occured during procedure." incident report form submitted for this complaint indicates 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: david vu ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 18003348
• Report Number: 3014162263-2023-00061
• Device Sequence Number: 20495783
• Product Code: HCG
• UDI-Device Identifier: 00818053025891
• UDI-Public: (01)00818053025891(11)220625(17)270625(10)F220601071
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 10/23/2023

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: OPTI0308CSS10
• Device Lot Number: F220601071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2022
• 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: Other
• Patient Sex: Unknown