MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG HELICAL XTRSOFT COIL 2X6; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640HX0206
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg initial reporter phone: (b)(6).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2022-00257.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by the field, during a coil embolization, a 2x6 orbit galaxy coil (640hx0206, 30574615) could not be detached, the physician raised pressure to red area, but the coil still could not detach.The second coil, a 2x8 galaxy xtrasoft coil (640hx0208, 30546086) had the same issue.The third device was used to complete the surgery.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a coil embolization, a 2x6 orbit galaxy coil (640hx0206, 30574615) could not be detached, the physician raised pressure to red area, but the coil still could not detach.The second coil, a 2x8 galaxy xtrasoft coil (640hx0208, 30546086) had the same issue.The third device was used to complete the surgery.There was no patient injury reported.The device was not returned for analysis; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30574615 number, and no non-conformances related to the malfunction were identified.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.Based on the minimal information provided, it is not possible to determine the root cause of the detachment failure.It was not reported whether the control cable or dcb were replaced during the procedure.It is also unknown if a pre-deployment electrical check was performed.The instructions for use (ifu) advises to verify that the microcoil delivery system is fully connected, and no faults are indicated on the dcb.If a fault exists, all connections between the dpu, the dcb, and the connecting cable should be reseated.If a fault still persists, the connecting cable should be replaced.If this does not correct the error, the dcb should be replaced.If the microcoil delivery system still continues to have a fault, the microcoil system should be retrieved and replaced with a new microcoil system.After depressing the detach button on the dcb or control cable (if the system is free of faults), the dcb should be replaced if the light and audible tone do not activate.Also, if a fault light is detected, the system ready light is not illuminated, or there is no detachment after two detachment attempts, the dcb should be replaced.If detachment still does not occur, the microcoil system should be carefully withdrawn and replaced.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.
Additional Manufacturer Narrative
Product complaint (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3, h6 and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion updated with device analysis: as reported by the field, during a coil embolization, a 2x6 orbit galaxy coil (640hx0206, 30574615) could not be detached, the physician raised pressure to red area, but the coil still could not detach.The second coil, a 2x8 galaxy xtrasoft coil (640hx0208, 30546086) had the same issue.The third device was used to complete the surgery.There was no patient injury reported.A non-sterile og helical xtrsoft coil 2x6 was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and no apparent damage was observed.Further inspection under microscopic magnification revealed that the embolic coil was kinked and remains attached to the rest of the device.It can be noted inside the introducer.No other damage was found on the device.The functional test was performed, a lab sample prowler select plus was flushed with a lab sample syringe then the og helical xtrsoft coil 2x6 was introduced, and the device was purged into the blue zone; after that, the pressure gauge was increased to the green zone and before reaching this point the coil was detached without any difficulty.A manufacturing record evaluation was performed for the finished device 30574615 number, and no non-conformances related to the malfunction were identified.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.The customer complaint regarding a coil failure to detach was not able to be confirmed based on the findings during the functional test, procedural factors may contribute to the reported failure since no abnormalities were found in the device that contribute to the complaint.It was not reported whether the control cable or dcb were replaced during the procedure.It is also unknown if a pre-deployment electrical check was performed.The instructions for use (ifu) advises to verify that the microcoil delivery system is fully connected, and no faults are indicated on the dcb.If a fault exists, all connections between the dpu, the dcb, and the connecting cable should be reseated.If a fault still persists, the connecting cable should be replaced.If this does not correct the error, the dcb should be replaced.If the microcoil delivery system still continues to have a fault, the microcoil system should be retrieved and replaced with a new microcoil system.After depressing the detach button on the dcb or control cable (if the system is free of faults), the dcb should be replaced if the light and audible tone do not activate.Also, if a fault light is detected, the system ready light is not illuminated, or there is no detachment after two detachment attempts, the dcb should be replaced.If detachment still does not occur, the microcoil system should be carefully withdrawn and replaced.The kinked condition of the embolic coil was not originally reported in the complaint.However, coil kinking is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issue from occurring.Kinking can occur during procedure handling where force may have been inadvertently applied.This condition seem to be unrelated to the reported issue as it did not affect the detachment process during the functional test.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that product failure could be caused by multiple factors.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

• Brand Name: OG HELICAL XTRSOFT COIL 2X6
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14014880
• Report Number: 3008114965-2022-00256
• Device Sequence Number: 4558814
• Product Code: KRD
• UDI-Device Identifier: 10886704030720
• UDI-Public: 10886704030720
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2022

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: 04/30/2023
• Device Model Number: 640HX0206
• Device Catalogue Number: 640HX0206
• Device Lot Number: 30574615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 06/03/2022; 07/12/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 06/06/2022; 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OG HELICAL XTRSOFT COIL 2X8.
• Patient Sex: Unknown