MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number OPTI0720CSFMX

Device Problems Stretched (1601); Migration (4003); Premature Separation (4045)

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

Event Date 02/14/2024

Event Type  malfunction  

Event Description

It was reported that: "patient information: sex: 75 years old female.Disease name: 7mm of an in ic-pc.Procedure: planned procedure.Micro catheter: greach/tokai medical.Assist stent: unknown.Y connector: unknown.Used coils: avenir/jll.Description: the physician experienced 2 unravel events.Optimax: 7mm-20cm (reported as ya2023-1095) tima 2mm-8cm(ya2023-1097) ya2023-1095: it was double catheter procedure.Using greach/tokai medical micro catheters, optimax(7-20) and (6-15) were deployed alternately but it was difficult to wind off the two coils at the same time and attempts were made to re-implant them over 20 times.After that, the 6-15 was detached first and another coil with 5-10 was inserted.During attempt to deployment, the coil 7-20 got unraveled.Thus, the physician tried to retrieve the coils.The coil with 5-10 was retrieved successfully but 7-20 was detached while attempting to retrieve it with a microcatheter and snare.At this time, part of the coil will be in the mother vessel by about 3 cm.To treat it, sl10 was guided, a stent (atlas 4-21/striker) was deployed, and the remaining coil was crimped to the mass wall and the procedure continued." incident report form submitted for this complaint indicates that no patient injury was sustained.

Manufacturer Narrative

Balt usa reference # (b)(4).An evaluation of the actual complaint sample could not be performed as device was unavailable to be return.Based on the provided information, root cause could not be definitively determined.Lack of device return prevented deeper evaluation of the reported issue.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 f231100176 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: 18912491
• MDR Text Key: 337766142
• Report Number: 3014162263-2024-00008
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053025235
• UDI-Public: (01)00818053025235(11)231106(17)281106(10)F231100176
• 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
• Report Date: 03/15/2024

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPTI0720CSFMX
• Device Lot Number: F231100176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2023
• 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