MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0203CSS10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa's reference number: (b)(4).The returned device was inspected in our quality laboratory.During our analysis: we observed only the delivery pusher to be available for return, no implant or introducer sheath; we observed the detachment zone to show no visual signs of a detachment cycle being ran; we observed the electrical resistance of the delivery pusher to be 42.7[?] - within specification; we observed a minor bend found along the delivery pusher approximately 10cm distal of the first warning stripe.Root cause of the premature detachment of the implant cannot definitively be determined.During our investigation, we observed the detachment zone to show no visual indication of a detachment cycle being ran, as well as no visual damage to the detachment zone.It is possible that during the procedure, the implant unintentionally interacted with a secondary device while the physician attempted to remove the coil system.Without the return of the implant, it is difficult to definitely say if the implant was damaged prior to the premature detachment, which could have caused the friction felt while attempting to retract the coil system.It is likely that the minor bend found in the delivery pusher was from the physician attempting to retract the device while friction was felt.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 f191100237 has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.
Event or Problem Description
It was reported that: "the physician was balloon assist coiling a ruptured mca birfurcation aneurysm.The physician had previously used a 2.5x6 axium, then optima 2x6 css, optima 2x4 css.The coil mass wasn't sitting well due to wide neck.The physician used the balloon to push the coils back into the anuerysm.The physician added an additional 2x3 optima css and it packed and held the coils in place.The physician was using an additional 2x3 optima css.The physician didn't like how the coil was sitting and decided to pull out the coil.The physician felt some friction when removing and continued to pull on pusher to the remove the coil and the coil broke off the pusher at the detachment zone leaving the coil half in the micro catheter.The physician used a syringe filled with saline to push the coil out of microcatheter.The physician had to use an atlas stent to secure the coils down.The physician believes he had trapped the coil on the side wall between the catheter and balloon.The physican doesn't believe the coil was tangled.Pusher available for return, not coil.".

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• MDR Report Key: 11571181
• Report Number: 3014162263-2021-00013
• Device Sequence Number: 4455492
• Product Code: HCG
• UDI-Device Identifier: 00818053025785
• UDI-Public: 00818053025785
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K172390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2021
• Device Model Number: OPTI0203CSS10
• Device Catalogue Number: N/A
• Device Lot Number: F191100237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention