MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number OPTI0830CSFMX

Device Problems Stretched (1601); Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2024

Event Type  malfunction  

Event Description

It was reported that: " sex: unknown disease name: 10mm an in ic-top procedure: emergency procedure micro catheter: sl-10/stryker assist stent: unknown y connector: unknown used coils: optimax, 2 targetxcel/stryker after placing 1 optimax coil and 2 targetxcel coils, the physician inserted optimax 8×30(reported coil).The physician performed several attempts of repositioning.After repeated attempts, the physician found that, despite he operated delivery wire the implant coil(the tip of it was placed in the target lesion) did no move no longer.It turned out that the implant coil got unraveled and retrieving attempt with snare were difficult.Eventually, the implant coil was torn off and partially remained in the aneurysm and some part of filament remained in the mother vessel.After that the procedure was continued with competitive coils and the loop of coil has been pushed out of the aneurysm.Thus the physician completed procedure by jacking up the stent and holding down part of the optimax strand with the stent, although it was a sah.It is unknown whether the physician performed before use check or not." incident report form submitted for this complaint indicates that no patient injury was sustained.

Manufacturer Narrative

Balt usa reference (b)(4).Investigaiton pending the return of the complaint device for analysis.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
• Type of Device: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 18741638
• MDR Text Key: 335813206
• Report Number: 3014162263-2024-00005
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053025259
• UDI-Public: (01)00818053025259(11)231108(17)281108(10)F231100305
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPTI0830CSFMX
• Device Lot Number: F231100305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention