MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0820CSFMX
Medical Device Problem Codes	Expulsion (2933); Poor Visibility (4072)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the physician was coiling a ruptured pcom aneurysm.He was framing with this 8x20 optimax.He realized that the coil did not have a proximal 3cm coiling marker.He visualized bringing the coil to the tip of the microcather to detach.He said he tried deploying 4 times before the coil detached.There was a loop of the coil in the parent artery but he brought up a scepter balloon to tack that loop into the aneurysm, added more coils to secure, and came out with a nice result.The physician was really annoyed with the fact this happened and that he missed it, but had never seen anything like this before." (b)(6) 2022, additional information from physician - "coiling a ruptured pcom.To be honest, it threw me off so much i detached it not realizing it was partially in ica now.".
Additional Manufacturer Narrative
Balt usa reference number: # (b)(4).Additional narrative pending completion of investigation.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.
Additional Manufacturer Narrative
Balt usa reference number: #(b)(4).The returned device was inspected in our quality laboratory.During our analysis: - we noted that the implant coil was not returned; - we observed no visual damage to the detachment zone, with the lead wires and solder joints intact; - we observed the detachment zone to show signs of a detachment cycle occurring; - we observed no visual damage to the introducer sheath; - we observed no visual damage to the delivery pusher; - we observed the ro coil to be intact on the delivery pusher with the two laser welds identified along the body coil.Root cause of the deployment issues cannot definitively be determined, however the ro coil was found to be intact along the delivery pusher.Upon device return, no visual damage was observed at the detachment zone, with the lead wires and solder joints intact, however, signs of a detachment cycle being conducted were observed.Further device analysis showed that the ro coil was intact along the delivery pusher with the two laser welds identified along the body coil.Review of the lhr indicates no abnormalities within the delivery pusher subassembly for all released units for lot f220701299.The delivery pusher subassembly contains the radiopaque marker which is visible under fluoroscopy.The delivery pusher was compared under fluoroscopy with an in-house control coil system.When compared to the in-house control coil system, the ro coil marker of the returned delivery pusher visually appeared less radiopaque than that of the delivery pusher from the in-house control coil system, confirming the reported visibility issue endured by the user.Further material assessment was performed on the ro coil component of the returned delivery pusher.The test results of the elemental scan did indicate trace amounts of the expected elemental composition, however the exact quantity required for satisfactory visual radiopaqueness is unknown - therefore the quantitative results are unable to be compared to that of the delivery pusher from the in-house control coil system.A review of our post-market surveillance program was conducted following the device analysis, which indicated that only three incidents including this complaint have ever been reported for a similar visibility issue on the optima coil system regarding the delivery pusher.For these three incidents, only for this specific instance was the reported failure able to be confirmed.The manufacturing and receiving records for this manufacturing lot do not indicate any abnormality which could have contributed to the reported failure.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 f220701299 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 was coiling a ruptured pcom aneurysm.He was framing with this 8x20 optimax.He realized that the coil didn't have a proximal 3cm coiling marker.He visualized bringing the coil to the tip of the microcather to detach.He said he tried deploying 4 times before the coil detached.There was a loop of the coil in the parent artery but he brought up a scepter balloon to tack that loop into the aneurysm, added more coils to secure and came out with a nice result.The physician was really annoyed with the fact this happened and that he missed it but had never seen anything like this before." on 23 sep 2022, additional information from physician - "coiling a ruptured pcom.To be honest, it threw me off so much, i detached it not realizing it was partially in ica now".

• 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: 15653333
• Report Number: 3014162263-2022-00033
• Device Sequence Number: 5965809
• Product Code: HCG
• UDI-Device Identifier: 00818053025242
• UDI-Public: 00818053025242
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/04/2023

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: OPTI0820CSFMX
• Device Catalogue Number: N/A
• Device Lot Number: F220701299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• 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