MAUDE Adverse Event Report: BALT USA, LLC OPTIMA COIL SYSTEM

Model Number	OPTI0620CST0
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Codes	Aneurysm (1708); Patient Problem/Medical Problem (2688)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To whom it may concern: on march 11, 2019, we received a complaint regarding the use of a single optima coil (6mm x 20cm complex standard coil)."treatment of a ruptured left sylvian bifurcation aneurysm: a first optima coil was inserted through an echelon 14, 45 degrees without any problems (opti0724cst10, lot 072518a-050).A second coil opti0620cst10 was positioned into the aneurysm.While repositioning the coil by resheathing him, the coil detached spontaneously in the catheter.One part of the coils was trapped in the aneurysm by the first coil and the other part floated into the echelon.The end of the procedure was extremely challenging because the proximal part of the coil migrate in an upper branch and started to close it.The dr tried to capture the coil with a lasso but it was impossible and he stretched the coil.At the end, the proximal part of the stretched coil was removed from the upper branch and placed in the external carotid with a scepter c balloon, where it was less dangerous for the patient.Then, they filled the aneurysm to treat it." the results of our investigation following return of the affected device are summarized as follows: visual evaluation revealed the implant coil not attached to the delivery pusher.The proximal 30mm of coil was received, the rest of the coil remained in the patient.Customer reported that the coil self-detached during repositioned no attempt at detachment via the controller was performed.The device pusher wire was visually inspected, and it appeared that the sr thread had fractured distally to the attachment bond.The attachment knot was present and visible.About 45mm of stretch resistant thread was protruding out of the proximal end of the implant coil.The stretch resistant thread end was white/opaque the expected failure mode of a tensile overload failure.Based on the available information and the investigation results the reported complaint was confirmed.The root cause of this complaint cannot be determined; however, it is possible by the condition of the coil that it was stretched and exposed to a force greater than the tensile strength of the coil resulting in a fracture of the implant.The fracture of the implant coil subsequently leads to the separation of the implant coil from the pusher.Review of the lot history records for the reported lots did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number 061818b have 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: "treatment of a ruptured left sylvian bifurcation aneurysm: a first optima coil was inserted through an echelon 14, 45 degrees without any problems (opti0724cst10, lot 072518a-050).A second coil opti0620cst10 was positioned into the aneurysm.While repositioning the coil by resheathing him, the coil detached spontaneously in the catheter.One part of the coils was trapped in the aneurysm by the first coil and the other part floated into the echelon.The end of the procedure was extremely challenging because the proximal part of the coil migrate in an upper branch and started to close it.The dr tried to capture the coil with a lasso but it was impossible and he stretched the coil.At the end, the proximal part of the stretched coil was removed from the upper branch and placed in the external carotid with a scepter c balloon, where it was less dangerous for the patient.".

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA COIL
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• MDR Report Key: 8469385
• Report Number: 3014162263-2019-00002
• Device Sequence Number: 1486791
• Product Code: HCG
• UDI-Device Identifier: 00818053021848
• UDI-Public: 00818053021848
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K172390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2019

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: 06/18/2020
• Device Model Number: OPTI0620CST0
• Device Lot Number: 061818B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 04/01/2019
• 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: Hospitalization