MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0611CSFMX
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa's reference number: (b)(4).An evaluation of the actual complaint sample could not be performed as the device was unavailable for return.Based on the provided information, root cause could not be definitively determined.Lack of device return prevented deeper evaluation of the reported issue.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 f201100111 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 tried repositioning the optimax soft 6x11 4 times.Decided to pull coil out and try a optimax 5x7.One loop was left in the aneurysm and the coil detached.He decided to push the coil in but one of the loops protruded in the a2.Tried to wire a2 but could not.Left patient as is.Will retry tomorrow." follow up ((b)(6) 2021): "the physician had to advanced the coil into the aneurysm with the pusher after it prematurely detached.He could not pull the coil out because it was through a stent and he did not want to risk the stent moving proximately.Unfortunately one of the loops of the coil protruding into the a1 segment.He tried multiple wires to get around the loop to put in another stent but could not do it and did not want to risk moving the stent that had already been placed in a2.He has decided to wait six weeks from the procedure date, hoping the stent and possibly the protruded loop may endothelialize.At that point in time he will make a decision on what the next steps will be.".
Additional Manufacturer Narrative
Balt usa's reference number: (b)(4).Follow up (24-aug-2021): "i spoke with dr.Gupta.The follow-up on this patient was fine.There were no issues." an evaluation of the actual complaint sample could not be performed as the device was unavailable for return.Based on the provided information, root cause could not be definitively determined.Lack of device return prevented deeper evaluation of the reported issue.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 f201100111 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 or Problem Description
It was reported that: "the physician tried repositioning the optimax soft 6x11 4 times.Decided to pull coil out and try a optimax 5x7.One loop was left in the aneurysm and the coil detached.He decided to push the coil in but one of the loops protruded in the a2.Tried to wire a2 but could not.Left patient as is.Will retry tomorrow." follow up (06-jul-2021): "the physician had to advanced the coil into the aneurysm with the pusher after it prematurely detached.He could not pull the coil out because it was through a stent and he did not want to risk the stent moving proximately.Unfortunately one of the loops of the coil protruding into the a1 segment.He tried multiple wires to get around the loop to put in another stent but could not do it and did not want to risk moving the stent that had already been placed in a2.He has decided to wait six weeks from the procedure date, hoping the stent and possibly the protruded loop may endothelialize.At that point in time he will make a decision on what the next steps will be." follow up (24-aug-2021): "i spoke with dr.Gupta.The follow-up on this patient was fine.There were no issues.".

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• MDR Report Key: 12139957
• Report Number: 3014162263-2021-00026
• Device Sequence Number: 11615802
• Product Code: HCG
• UDI-Device Identifier: 00818053025198
• UDI-Public: 00818053025198
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: 11/12/2025
• Device Model Number: OPTI0611CSFMX
• Device Catalogue Number: N/A
• Device Lot Number: F201100111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 08/31/2021
• 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