MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 6X20; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CF0620
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that a patient was suffering from a right internal carotid communicating segment aneurysm underwent a stent-assisted aneurysm embolization procedure.During the procedure, the 6mm x 20cm orbit galaxy complex fill coil (640cf0620 / 30478001) was advanced through the concomitant microcatheter to reach the target position, the physician was attempting to adjust the coil, but it prematurely detached.It was reported that the physician did not touch the syringe.Another device was used to complete the procedure.There was no report of any patient adverse event or complication.On 10 august 2021, additional information was received.The information indicated that the target lesion was on the right internal carotid artery (ica) c6 segment; the diameter of the aneurysm is 6mm.The information indicated that the 6mm x 20cm orbit galaxy complex fill coil prematurely detached at the detachment zone on the device positioning unit.The embolic coil did not become separated into two or more pieces.The event did not result in reduced / restricted blood flow in the parent vessel.There was no evidence of thrombosis.The complaint coil was used with the frepass® microcatheter (lepu medical) which was used with previous coils in the procedure.The reported event did not result in any clinically significant procedure delay.The procedure was completed with a competitor coil.The additional information included one medical image to capture the vessel tortuosity.The image was reviewed by a medical affairs consultant, neurovascular surgeon on (b)(6) 2021.The review assessment is as follows: "a complaint of premature detachment of a 6 mm x 20 cm orbit galaxy complex fill coil is made.The complaint is accompanied by a single lateral image of a coil positioned in an irregular right internal carotid artery aneurysm.There appears to be two microcatheters in the internal carotid artery.There is no significant tortuosity noted.The complaint states that the physician advanced the coil through the microcatheter and deployed in the aneurysm.Upon repositioning the coil, the coil detached without use of the syringe.No patient harm was noted and the procedure was able to be completed.Premature detachment is known but rare complication that can occur.Most frequently it occurs during manipulation of the coil position during retraction of the coil.The coil may tangle on itself and during retraction there maybe resistance and with further manipulation the coil may prematurely detach." (b)(6).
Additional Manufacturer Narrative
(b)(4).(b)(6).Information regarding patient identifier, month and date of birth, weight, race, and ethnicity were not provided.Procode is krd/hcg.(b)(6).The initial reporter email address was not reported.[conclusion]: the healthcare professional reported that a patient was suffering from a right internal carotid communicating segment aneurysm underwent a stent-assisted aneurysm embolization procedure.During the procedure, the 6mm x 20cm orbit galaxy complex fill coil (640cf0620 / 30478001) was advanced through the concomitant microcatheter to reach the target position, the physician was attempting to adjust the coil, but it prematurely detached.It was reported that the physician did not touch the syringe.Another device was used to complete the procedure.There was no report of any patient adverse event or complication.On 10 august 2021, additional information was received.The information indicated that the target lesion was on the right internal carotid artery (ica) c6 segment; the diameter of the aneurysm is 6mm.The information indicated that the 6mm x 20cm orbit galaxy complex fill coil prematurely detached at the detachment zone on the device positioning unit.The embolic coil did not become separated into two or more pieces.The event did not result in reduced / restricted blood flow in the parent vessel.There was no evidence of thrombosis.The complaint coil was used with the frepass® microcatheter (lepu medical) which was used with previous coils in the procedure.The reported event did not result in any clinically significant procedure delay.The procedure was completed with a competitor coil.The additional information included one medical image to capture the vessel tortuosity.The image was reviewed by a medical affairs consultant, neurovascular surgeon on (b)(6) 2021.The review assessment is as follows: "a complaint of premature detachment of a 6 mm x 20 cm orbit galaxy complex fill coil is made.The complaint is accompanied by a single lateral image of a coil positioned in an irregular right internal carotid artery aneurysm.There appears to be two microcatheters in the internal carotid artery.There is no significant tortuosity noted.The complaint states that the physician advanced the coil through the microcatheter and deployed in the aneurysm.Upon repositioning the coil, the coil detached without use of the syringe.No patient harm was noted and the procedure was able to be completed.Premature detachment is known but rare complication that can occur.Most frequently it occurs during manipulation of the coil position during retraction of the coil.The coil may tangle on itself and during retraction there maybe resistance and with further manipulation the coil may prematurely detach." (b)(6).Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30478001) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information provided in the complaint and without the product available for analysis, the reported issues by the customer cannot be confirmed.Based on the review of the manufacturing documentation, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: OG TDL CMPLX FILL COIL 6X20
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 12320904
• Report Number: 3008114965-2021-00359
• Device Sequence Number: 17177713
• Product Code: KRD
• UDI-Device Identifier: 10886704030348
• UDI-Public: 10886704030348
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

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: 09/30/2022
• Device Model Number: 640CF0620
• Device Catalogue Number: 640CF0620
• Device Lot Number: 30478001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FREPASS® MICROCATHETER (LEPU MEDICAL)
• Patient Age: 22 YR