MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number OPTI0253CSS10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rupture (2208)

Event Date 11/26/2023

Event Type  Injury  

Manufacturer Narrative

Balt usa reference (b)(4).Investigation pending return 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 Description

It was reported that: "it was a case of ruptured aneurysm at the origin of pica measuring 3mmx2.5mm with a neck of 2.31mm.The physican planned to do simple coiling.The support system was ballast 80cms and fargomax 6f 105, the vasco 10 mp was placed inside the aneurysm with support of hybrid 12/14 da.Vasco 10 mp was connected with a flush line.The first coil barricade complex frame 2.5*5 was prepared as per ifu and then aligned to the hub of the micro catheter.On pushing the coil there was resistance felt inside the micro and upon resheathing to check it was found that the coil was coming out streched.The coil was removed and the next coil was optima complex 10 soft 2.5*5 and the coil was prepared as per ifu and aligned to the hub of the micro and coil being pushed the initial coil went in smooth till the time that the flurosafe markers were entering the proximal part of the sleeve resistance was felt ,upon resheathing it was noticed that the coil shape had changed and some kinks seens in the delivery system.The physcian choose optima complex 10 super soft 2.5*3 and prepared the coil as per ifu and the coil in the same micro went in without any issues but once the coil came out of the micro it ruptured the aneurysm.An eclipse 2l 6*20 was taken and procedure was completed using a combination of optima and barricade the procedure was completed." update 29feb2024 - additional information received from the issuer: "1.What is the patient's current condition? patient doing good 2.How did the case conclude, or was there any additional procedures required that are were not mentioned? yes patient went for evd after rupture of aneurysm 3.What was the cause of the aneurysm rupture (was the aneurysm ruptured before the procedure or did it occur during the procedure)? it occurred during procedure 4.Did the case involve tortuous anatomy/ was this a challenging case? no it's was not tortous anatomy 5.Is the microcatheter available for return? no microcather was not given his institute".

• 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: 18912479
• MDR Text Key: 337759714
• Report Number: 3014162263-2024-00007
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053025839
• UDI-Public: (01)00818053025839(11)230719(17)280719(10)F230700503
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K172390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPTI0253CSS10
• Device Lot Number: F230700503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/19/2023
• 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): Life Threatening; Required Intervention; Hospitalization