MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number OPTI0306CSS10

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907)

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

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Balt usa's reference number: (b)(4).The returned device was inspected in our quality laboratory.During our analysis: we observed the implant to be detached from the coil system.The detached implant was not returned with the coil system; we observed the detachment zone to show no indication of an attempted detachment cycle; we observed no visual damage to the delivery pusher.Root cause of the premature detachment cannot definitively be determined, but it is likely that the premature detachment was caused from repositioning the device during the procedure.It is possible that during the procedure, the implant became snagged on a secondary device.The unintended interaction with the secondary device could have caused the premature detachment of the implant.Without the return of the implant, it cannot be determined if the implant interacted with a secondary device.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 f200800177 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 Description

It was reported that: "it was the first coil (target 3x8) to embolism aneurysm, but, the coil (target 3x8) was retrieved due to mismatch of coil size.When the second (optima 3×6) coil was inserted to the end, the coil came out of the aneurysm.Therefore, when the coil was pulled back once and inserted about 2 ~ 3 loops, the coil was unintentionally detached, and some part of the coil was hanging from the aneurysm about 4cm.Therefore, a stent (4.5 x 3 neuroform atlas / stryker) was placed to lock coil and the procedure was completed." follow up (08-dec-2020): "the stent had been positioned to cover the aneurysm from the beginning.After that, the coil placement was started.Patient's vessel condition: no tortuous was observed.After the coil was pulled back once and the coil inserted about 1loops, the doctor said that the coil suddenly stopped moving.And when the coil inserted about 2~3 loops, the coil was early detached." follow up (27-jan-2021): for complaint (b)(4), was the stent placed before the coiling or was placed after the incident? i did a follow up and was told it was placed before the coiling began."a total of two stents were placed in the patient.(the first stent was placed before the coiling.The second stent was placed after the incident.".

• Brand Name: OPTIMA COIL SYSTEM
• Type of Device: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 11243948
• MDR Text Key: 230955833
• Report Number: 3014162263-2020-00044
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053021534
• UDI-Public: 00818053021534
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPTI0306CSS10
• Device Catalogue Number: N/A
• Device Lot Number: F200800177
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2020
• 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