MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI2265COM18
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa's reference number: (b)(4).To whom it may concern: on august 06, 2020, balt usa has been notified of an event regarding the use of a single optima coil.Details reported as follows: "the case was acom narrow neck aneurysm measuring 25mmx18mm and neck measured 6mm.The physician planned to do simple coiling of the aneurysm.The support hardware was 8f neuronmax ,6f fargomax ,vasco 10d & traxcess guide wire.The coils used were complex18 22x65-2no,20x65-2no,14x47-1no,complex10standard10x34-1no.The last coil was optima helical standard10x30-1no to complete the procedure.Out of the complex18- 22x65 got pre maturely detached and the same was retrieved by using vasco 21 and solitaire stent retriever.We were not able to collect the device pushwire, coils and micro cath as the patient was suspected for covid 19 and all the them were discarded as per hospital policy.But we were able to get the recorded images." 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 record for the reported lot was performed.Customer feedback has been noted for lot 101619b; however, there is no in-process issue that could account for the observation.This lot will remain subject to monitoring for any unacceptable increase in trend.
Event or Problem Description
It was reported through an automated reporting system from active clinical study: "the case was acom narrow neck aneurysm measuring 25mmx18mm and neck measured 6mm.The physician planned to do simple coiling of the aneurysm.The support hardware was 8f neuronmax ,6f fargomax ,vasco 10d & traxcess guide wire.The coils used were complex18 22x65-2no,20x65-2no,14x47-1no,complex10standard10x34-1no.The last coil was optima helical standard10x30-1no to complete the procedure.Out of the complex18- 22x65 got pre maturely detached and the same was retrieved by using vasco 21 and solitaire stent retriever.We were not able to collect the device pushwire, coils and micro cath as the patient was suspected for covid 19 and all the them were discarded as per hospital policy.But we were able to get the recorded images.".

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine, ca
• MDR Report Key: 10456781
• Report Number: 3014162263-2020-00017
• Device Sequence Number: 3073692
• Product Code: HCG
• UDI-Device Identifier: 00818053022067
• UDI-Public: 00818053022067
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K172390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: OPTI2265COM18
• Device Catalogue Number: N/A
• Device Lot Number: 101619B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/26/2020
• 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