MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0620COM18
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference (b)(4).Conclusion of investigation pending return and analysis of the suspected device.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: "it was a case of ruptured acom aneurysm having two lobes the physican planned to do simple coiling.The support system was neuronmax and navien5f, the headway 17 was placed inside the aneurysm with support of traxcess14.Headway 17 was connected with a flush line.The first coil optima 4*13 complex 10 soft was prepared as per ifu and then aligned to the hub of the micro catheter.The first lobe was coiled.The second coil size of 5*17 optima complex10 soft was prepared as per ifu and then aligned to the hub of the micro catheter.The coil went smoothly through the sleeve into the hub of headway 17 and during coiling the physcian felt resistance and a give away feel so he decided not to continue with coil and retrieved it.The coil was pushed in saline bowl to check the coil , he noticed that the coil was kind of streched.He decided to use optima complex 18 6*20,it was prepared as per ifu.Then aligned to the hub of the micro catheter.The coil went smoothly through the sleeve into the hub of headway 17, after two loops of the coil inside the aneurysm the physcian was pushing the coil but the coil was not moving later the physician was reterving coil but no movement was happening.Coil had pre-detached.The coil was removed with the help of catchmaxi6*40, coil been taken out the physician decided to abandon the procedure." incident report form submitted for this complaint indicates that no patient injury was sustained.
Event or Problem Description
It was reported that: "it was a case of ruptured acom aneurysm having two lobes the physican planned to do simple coiling.The support system was neuronmax and navien5f, the headway 17 was placed inside the aneurysm with support of traxcess14.Headway 17 was connected with a flush line.The first coil optima 4*13 complex 10 soft was prepared as per ifu and then aligned to the hub of the micro catheter.The first lobe was coiled.The second coil size of 5*17 optima complex10 soft was prepared as per ifu and then aligned to the hub of the micro catheter.The coil went smoothly through the sleeve into the hub of headway 17 and during coiling the physcian felt resistance and a give away feel so he decided not to continue with coil and retrieved it.The coil was pushed in saline bowl to check the coil , he noticed that the coil was kind of streched.He decided to use optima complex 18 6*20,it was prepared as per ifu.Then aligned to the hub of the micro catheter.The coil went smoothly through the sleeve into the hub of headway 17, after two loops of the coil inside the aneurysm the physcian was pushing the coil but the coil was not moving later the physician was reterving coil but no movement was happening.Coil had pre-detached.The coil was removed with the help of catchmaxi6*40, coil been taken out the physician decided to abandon the procedure.".Incident report form submitted for this complaint indicates that no patient injury was sustained.
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 and implant coil was not included with the device return; - we observed upon return of the coil system, the implant coil was detached from the delivery pusher; - we observed no sign of detachment cycle being ran; - we observed the heater coil and pet jacket at the detachment zone to be damaged; - we observed multiple minor and major kinks along the hypotube; - we conducted destructive testing of the delivery pusher to reveal the detachment profile of the sr thread; - we observed the tip of the sr thread experienced necking - indicating the thread endured an overload in tensile stress.Root cause of the reported issue can likely be attributed to an overload of tensile stress exerted on the implant coil.Upon return of the device, we observed no sign of detachment cycle being ran.In addition, we observed the profile of the distal tip of the sr thread to indicate that the thread endured an overload in tensile stress.Without the return of the implant coil its exact condition is unknown, however it is possible that the implant coil had become damaged during attempts to introduce the coil system, then resulting attempts to retract the delivery pusher ultimately led to the premature detachment.If the implant coil were to become damaged, this could have caused excessive friction to be endured by the implant coil, causing resistance within the microcatheter hub.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.This could not be further investigated without the return of the associated microcatheter.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 complaint against lot number f220200919 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 (Section G): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 19806284
• Report Number: 3014162263-2024-00050
• Device Sequence Number: 7394896
• Product Code: HCG
• UDI-Device Identifier: 00818053026423
• UDI-Public: (01)00818053026423(11)220225(17)270225(10)F220200919
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 10/07/2024

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: OPTI0620COM18
• Device Lot Number: F220200919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• 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: Required Intervention
• Patient Sex: Unknown