MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI2525CSSMX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa's reference number: (b)(4).To whom it may concern: on august 27, 2020, balt usa has been notified of an event regarding the use of a single optima coil.Details reported as follows: "after framing with the 2.5x2.5 optimax the physician detached the coil and opened a 1x1 optimax but when he went to place the coil he noticed his microcatheter had come back.He pulled the coil out used the hybrid 1214 to access the aneurysm but when he inserted the sl-10 over the wire into the aneurysm it dislodged the 2.5z2.5 optimax.The physician dropped an atlas stent through the coil and across the neck of the aneurysm and then crossed the stent and placed 5 optima coils to finish the procedure.I have included images of the initial frame, stented 2.5x2.5 and the final result." based on the provided information, root cause can be attributed to a procedural complication.While trying to reaccess the aneurysm the optima coil was dislodged from its initial positioning.Review of the lot history records did not reveal any in-process issue that could account for the observation.No additional complaints against lot number f200500099 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: "after framing with the 2.5x2.5 optimax the physician detached the coil and opened a 1x1 optimax but when he went to place the coil he noticed his microcatheter had come back.He pulled the coil out used the hybrid 1214 to access the aneurysm but when he inserted the sl-10 over the wire into the aneurysm it dislodged the 2.5z2.5 optimax.The physician dropped an atlas stent through the coil and across the neck of the aneurysm and then crossed the stent and placed 5 optima coils to finish the procedure.I have included images of the initial frame, stented 2.5x2.5 and the final result.".

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• MDR Report Key: 10543953
• Report Number: 3014162263-2020-00018
• Device Sequence Number: 14337177
• Product Code: HCG
• UDI-Device Identifier: 00818053025013
• UDI-Public: 00818053025013
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 09/03/2020

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: 05/15/2025
• Device Model Number: OPTI2525CSSMX
• Device Catalogue Number: N/A
• Device Lot Number: F200500099
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/16/2020
• 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