MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number OPTI0306CSS10

Device Problems Contamination /Decontamination Problem (2895); Insufficient Information (3190)

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

Event Date 10/03/2023

Event Type  malfunction  

Event Description

It was reported that: "patient information: sex: unknown.Disease name: an.Procedure: planed tae.Micro catheter: unknown.Used coils: unknown.Description: when the physician removed package of optima and tried to advanced implant coil as before use check, the physician found brown substance in the lumen of introducer sheath and the coil would not advance.Then the physician opened new optima with same size to complete procedure.

Manufacturer Narrative

Balt usa reference (b)(4).Investigation pending return of 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: " sex: unknown.Disease name: an.Procedure: planed tae.Micro catheter: unknown.Used coils: unknown. when the physician removed package of optima and tried to advanced implant coil as before use check, the physician found brown substance in the lumen of introducer sheath and the coil would not advance.Then the physician opened new optima with same size to complete procedure.".

Manufacturer Narrative

Balt usa reference #(b)(4).The returned device was inspected in our quality laboratory.During our analysis: we observed the complete coil system was included with the device return; we noted that the returned coil was able to be introduced through the returned introducer sheath; we observed no kinks or visual damage to the implant coil; we observed no visual damage to the detachment zone with the pet jacket, lead wire and solder joints intact; we noted the coil system was able to be introduced and completely advanced out of an in-house microcatheter using the returned introducer sheath.We noted that no foreign material or substance was visually identified throughout the entire introducer sheath and coil system.Root cause of the introduction issues endured by the coil system cannot be definitively determined as the returned coil system was able to function as intended with no problem found.During our investigation, no visual damage was found throughout the coil system or introducer sheath.Further device analysis revealed that the reported failure was unable to be replicated as the returned coil system was able to be introduced and completely deployed through an in-house microcatheter using the returned introducer sheath.Furthermore, it was reported that the physician found brown substance in the lumen of introducer sheath, however upon device return no foreign material was found throughout the entire coil system including the introducer sheath.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 f230400508 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
• 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: 18056174
• MDR Text Key: 327174361
• Report Number: 3014162263-2023-00064
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053025884
• UDI-Public: (01)00818053025884(1)230418(17)280418(10)F230400508
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPTI0306CSS10
• Device Lot Number: F230400508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• 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