MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0827CST10
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "it happened during the treatment of an unruptured paraopthalmic aneurysm in a female patient aged (b)(6).During the deployment and embolization with optima coil 8x27 it deployed by itself and goes to the lumen of the vessel, it could be retrieved with guidewire and a 27 catheter.The whole system is withdrawn and the complete coil could be removed from the vessel" follow up (b)(6) 2021.Additional information received from the issuer:" it deployed itself and went to the lumen of the vessel without before being pushed.So, the implant did detached from the delivery pusher.The implant in fact left the micro-catheter because it migrated to the vessel.What they did to retrieve it is that the used the smart catheter and the guidewire as to become a retriever lasso, so it was catched and pulled backward into the guiding catheter and then it was completely removed from the patient.I am hereby confirming that there was no patient injury during the incident.".
Additional Manufacturer Narrative
Balt usa reference #: (b)(4).Initial notification of the incident received on (b)(6) 2021.The results of the reportability evaluation on (b)(6) 2021 deemed this event as not reportable.Additional information received from the issuer on (b)(6) 2021, which resulted in the reportability evaluation deeming this event as reportable.Results of the investigation are pending return of the device to balt usa.
Event or Problem Description
It was reported that: "it happened during the treatment of an unruptured paraopthalmic aneurysm in a female patient aged 49.During the deployment and embolization with optima coil 8x27 it deployed by itself and goes to the lumen of the vessel, it could be retrieved with guidewire and a 27 catheter.The whole system is withdrawn and the complete coil could be removed from the vessel" follow up (b)(6) 2021 - additional information received from the issuer: "it deployed itself and went to the lumen of the vessel without before being pushed.So, the implant did detached from the delivery pusher.The implant in fact left the micro-catheter because it migrated to the vessel.What they did to retrieve it is that the used the smart catheter and the guidewire as to become a retriever lasso, so it was cached and pulled backward into the guiding catheter and then it was completely removed from the patient.I am hereby confirming that there was no patient injury during the incident.".
Additional Manufacturer Narrative
Balt usa reference #(b)(4).Initial notification of the incident received on (b)(6)2021.The results of the reportability evaluation on (b)(6) 2021 deemed this event as not reportable.Additional information received from the issuer on (b)(6) 2021, which resulted in the reportability evaluation deeming this event as reportable.The returned device was inspected in our quality laboratory.During our analysis: we noted that the guidewire used during the incident was returned; we noted that the delivery pusher and introducer sheath were not returned - only the implant coil returned; we observed a minor kink and minor coil stretching 6.5cm distal of the implant's proximal end; we observed minor coil stretching 12cm distal of the implant's proximal end; we observed minor coil stretching 3cm and 4.5cm proximal of the implant's distal end; we observed the implant coil to be crushed 3.5cm proximal of the implant's distal end; we observed the sr thread to be protruding out of the implant's proximal end with the thread being opaque in color; we noted that further detachment testing could not be conducted due to unreturned delivery pusher.Root cause of the reported issues endured by the coil system cannot be definitively determined.Upon device return, the implant coil was observed to be damaged, with minor coil stretching throughout the coil.Additional analysis showed the sr thread to be protruding out of the implant's proximal end with the thread being opaque in color.This color of the sr thread indicates that the thread was slowly stretched until fracture, likely caused by tensile overload.It is unknown whether the implant coil was damaged during insertion into the microcatheter, or if the microcatheter was damaged during use.If the implant was damaged prior to insertion, this could have contributed to possible friction in the microcatheter, thereby leading to the reported premature separation.However, further analysis of the device could not be conducted due to the unreturned delivery pusher.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
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 13078228
• Report Number: 3014162263-2021-00042
• Device Sequence Number: 4256214
• Product Code: HCG
• UDI-Device Identifier: 00818053026362
• UDI-Public: 00818053026362
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K172390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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: 05/26/2026
• Device Model Number: OPTI0827CST10
• Device Catalogue Number: N/A
• Device Lot Number: F210500610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown