MAUDE Adverse Event Report: BALT USA, LLC OPTIMA COIL SYSTEM

Model Number OPTI0517CSF10

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Aneurysm (1708); Patient Problem/Medical Problem (2688)

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

To whom it may concern: on april 17, 2019, balt usa received a complaint regarding the use of a single optima coil (5mm x 17cm complex soft coil).Details reported as follows: "the doctor was treating a 5.18mm x 5.78mm ruptured mca bifurcation aneurysm.The physician had two microcatheters(sl10) in the aneurysm, one with the optima coil and the other with a stryker 6x20 3d.As both coils were advanced to detachment zones, dr.(b)(6) attempted to detach the optima coil, the detacher blinked red and green as soon as the coil pusher was bottomed out.Dr.(b)(6) pressed the detachment button at least 10 times, after multiple failed attempts, a second detacher was opened with the same result.A third detacher was opened and the same events occurred.Dr.(b)(6) then attempted to withdraw the optima, approximately 4 cm of coil was pulled back when the coil and pusher detached.Dr.(b)(6) began withdrawing the microcatheter and coil which caused the stryker coil and optima coil to relocate to the mca artery.Dr.(b)(6) then went up with a gooseneck snare to retrieve the coil mass.He was able to snare the optima coil and microcatheter and removed them from the patient.Dr.(b)(6) was then able to use a wire and microcatheter to re- position the stryker coil back into the aneurysm.The case ended with no patient injury and is complication free." the results of our investigation following return of the affected device, are summarized as follows: an evaluation of the actual complaint coil sample could not be performed device was reported unavailable; however, we did receive one of the controllers for evaluation.Visual analysis of the controller revealed the exterior housing to be normal in appearance.No damage or excessive fluid residual was visible.The controller was tested inserting a pusher connector into the housing controller until the pusher bumps against the inside of the detachment controller.The audio was present, the led was flashing green and indication of normal current.10 additional detachment cycles were tested with the returned xcel controller.No failures were encountered after multiple rounds of testing in sequence.Detachment-related issues (including inability to detach and unexpected detachment) are well-understood failures for implantable coils.These types of failures are not infrequent nor unique to balt usa products, having an established history of occurrence across similar marketed devices for many years.Currently unexpected detachment on all lots is below threshold.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.Based on the provided information, root cause could not be definitively determined.Lack of return of the coil prevented deeper evaluation of the reported issue.For the controller no problem was found as it functioned as intended.Review of the lot history records for the reported lots did not reveal any in-process or lot-specific issue that could account for the observation.One additional complaint against lot number 021519a has been made for the same issue.Lack of return of the coil prevented deeper evaluation; therefore, the complaint was unconfirmed.

Event Description

It was reported that: "the doctor was treating a 5.18mm x 5.78mm ruptured mca bifurcation aneurysm.The physician had two microcatheters (sl10) in the aneurysm, one with the optima coil and the other with a stryker 6x20 3d.As both coils were advanced to detachment zones, dr.(b)(6) attempted to detach the optima coil, the detacher blinked red and green as soon as the coil pusher was bottomed out.Dr.(b)(6) pressed the detachment button at least 10 times, after multiple failed attempts, a second detacher was opened with the same result.A third detacher was opened and the same events occurred.Dr.(b)(6) then attempted to withdraw the optima, approximately 4 cm of coil was pulled back when the coil and pusher detached.Dr.(b)(6) began withdrawing the microcatheter and coil which caused the stryker coil and optima coil to relocate to the mca artery.Dr.(b)(6) then went up with a gooseneck snare to retrieve the coil mass.He was able to snare the optima coil and microcatheter and removed them from the patient.Dr.(b)(6) was then able to use a wire and microcather to re- position the stryker coil back into the aneurysm.The case ended with no patient injury and is complication free.".

• Brand Name: OPTIMA COIL SYSTEM
• Type of Device: OPTIMA COIL
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• Manufacturer Contact: charles yang ; 29 parker; irvine 92618 ; 9497881443
• MDR Report Key: 8605820
• MDR Text Key: 151898752
• Report Number: 3014162263-2019-00004
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053021756
• UDI-Public: 00818053021756
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2021
• Device Model Number: OPTI0517CSF10
• Device Catalogue Number: N/A
• Device Lot Number: 021519A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2019
• 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