MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0254CSS10
Medical Device Problem Code	Poor Visibility (4072)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "there was no visible radiopaque detachment t marker on the coil under fluro." 18aug2022, spoke with sales rep in person where he had mentioned that the tip of the coil got stuck at the tip of the eclipse balloon during the procedure due to no visibile t marker.Retracted eclipse with coil, flushed eclipse and used same eclipse with different coil after.07sep2022 - additional info received from the issuer "can you confirm which coil number this was during the case (1st coil used, 2nd coil used, etc.)? it was probably [the] 5th [coil]." incident report form received for this complaint indicated no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference (b)(4).Note: this complaint file is being reported late as part of a corrective action following an fda inspection.After a review of historical complaint files, it was determined that for this compaint the device failed to meet its performance specifications according to the initial claim submitted by the user.For these complaints, the potential harm did not lead to a serious injury or death, however the performance specification which was failed to be met for these complaints could have led to a serious injury or death based on the initial information that was reported to balt.The returned device was inspected in our quality laboratory.During our analysis: we observed the implant coil to be severely stretched at the proximal tip; we observed no visual damages to the detachment zone, with the pet jacket and sr thread intact; we observed the ro coil to be intact on the delivery pusher with the two laser welds identified along the body coil; we observed a second stretched implant coil to be returned with the reported coil system.Root cause of the deployment issues cannot definitively be determined as the ro coil was found to be intact along the delivery pusher.Upon device return, the implant coil was found to be severely stretched at the proximal tip.Stretching of the coil likely occurred when retracting the coil system.Moreover, a second stretched implant coil was returned with the reported coil system.The reported coil system was likely caught on the second stretched implant that was returned (reported coil was the 5th coil used during the procedure).Despite damages to the implant coil, there were no visual damages to the detachment zone with the pet jacket and sr thread intact.Further device analysis showed that the ro coil to be intact on the delivery pusher with the two laser welds identified along the body coil.Review of lhr indicates no abnormalities of the pusher subassembly for all released units for lot f210200502.The pusher subassembly contains the component making the coil visible under fluoroscopy.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 f210200502 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: 17573017
• Report Number: 3014162263-2023-00042
• Device Sequence Number: 18362185
• Product Code: HCG
• UDI-Device Identifier: 00818053021503
• UDI-Public: (01)00818053021503(11)210228(17)230228(10)F210200502
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/07/2023

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: 02/28/2023
• Device Model Number: OPTI0254CSS10
• Device Lot Number: F210200502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2021
• 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
• Patient Sex: Unknown