MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0254CSS10
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Malfunction
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 noted that the hypotube was found broken approximately 14.5cm proximal of the distal end of the hypotube; we observed the lead wires through the broken hypotube; we observed kinks along the hypotube, located 27cm and 58cm proximal of the hypotube's distal end; we observed discoloration on the hypotube along the spiral cuts; we observed the discoloration found along the hypotube's distal end to vary in yellow, brown, and red color; we noted the physical substance was underneath the pet tubing of the body coil and was unable to be removed without destructing the delivery pusher; we noted the physical substance was able to be mechanically removed from the hypotube surface after removing the pet tubing; we noted there were no visual signs of material degradation; we observed no visual damage or abnormalities to the implant coil or body coil; we observed no visual damage or abnormalities to the introducer sheath.Root cause of the reported issue regarding the discoloration of the hypotube cannot definitively be determined.Upon return of the device, the hypotube was returned broken with signs of discoloration near the distal end of the hypotube.The discoloration found along the hypotube was found beneath the pet tubing of the body coil, and was unable to be removed without destructing the delivery pusher.Once the delivery pusher was deconstructed by removing the pet tubing, the discoloration was identified at the distal end of the hypotube, along the location of the spiral cuts.After the pet tubing was removed, the physical substance was able to be mechanically removed from the surface of the hypotube.The implant and body coil of the coil system demonstrated no visual damage or abnormalities along those components.The risk associated with the discoloration found along the hypotube was assessed, and determined to be minimized due to the physical location.As the discoloration was found along the hypotube, beneath the pet jacket for the body coil, exposure to the discoloration was only possible by physically destructing the delivery pusher.Additional attempts to further investigate the root cause of the discovered discoloration were performed with the supplier of the hypotube component for the delivery pusher, however this did not lead to a clear indication of the root cause for the discoloration.A review of our post-market surveillance program was conducted following the device analysis, (b)(4).Review of the lot history records did not reveal any lot-specific issue that could account for the observation.No additional complaints against lot number f200900059 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: ": sex / age: female/unknown, location: ic-pc, size of target lesion: 7mm, procedure: planned tae for unruptured aneurysm, micro catheter: sl10/stryker, the other coils: target us/stryker.: when the physician tired to perform before use check, they noticed that there was black foreign substance 10=15 cm proximal from distal tip of the introducer sheath." incident report from 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: 17573004
• Report Number: 3014162263-2023-00040
• Device Sequence Number: 8877486
• Product Code: HCG
• UDI-Device Identifier: 00818053025846
• UDI-Public: (01)00818053025846(11)200914(17)250914(10)F200900059
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/03/2023

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: 09/14/2025
• Device Model Number: OPTI0254CSS10
• Device Lot Number: F200900059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2020
• 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