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

Model Number OPTI0407CSF10

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

To whom it may concern: on (b)(6) 2018, we received a complaint regarding the use of a single optima coil (4mm x 7cm complex soft coil)."coil did not detach, when it was being pulled back into the catheter before the physician realized it was not detached, it detached, and part of the coil was in the micro catheter.The physician pushed the coil into the aneurysm using the coil pusher wire.It pushed out into the parent artery and was then snared out.They physician completed the procedure with no patient complication".The results of our investigation following return of the affected device, are summarized as follows: the visual analysis revealed the delivery pusher with the implant coil not attached.The distal end of the implant coil exhibited a blooming tip on the stretch-resistant thread.By the condition of the device it is confirmed that the coil detached by electrical current however, it is unknown if it was detached at the first attempt.The physician stated that the coil was pushed into the aneurysm using the coil pusher wire.It pushed out into the parent artery and was then snared out.The aneurysm dimensions were 3.5mm x 5mm close to a wide neck with no stent placed to reinforce the coils.The coil prolapse may result from a variety of causes, including size mismatch between the coils and aneurysm, inadequate position of the microcatheter, coil instability after detachment, excessive embolization, microcatheter or stent related problems, or from being pushed by subsequent coil embolization.Prolapse occurred in aneurysms with wide or "loose" necks.Based on the provided information and the investigation results the reported complaint cannot be confirmed.The potential root cause to the unexpected detachment was due to the polymer sr thread diameter increasing after detachment.However, it cannot be determined what caused the coil to fall into the parent artery after detachment.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.No additional complaints against lot number 100118a have been made for the same issue.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.No additional complaints against lot number (lot number) have been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.

Event Description

It was reported that: "coil did not detach, when it was being pulled back into the catheter before the physician realized it was not detached, it detached, and part of the coil was in the micro catheter.The physician pushed the coil into the aneurysm using the coil pusher wire.It pushed out into the parent artery and was then snared out.They physician completed the procedure with no patient complication".

• 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: 8038452
• MDR Text Key: 127553257
• Report Number: 3009698517-2018-00013
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053021725
• UDI-Public: 00818053021725
• 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: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: OPTI0407CSF10
• Device Lot Number: 100118A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2018
• 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