MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3X6; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX0306
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.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 3x6 orbit galaxy xtrasoft coil (640cx0306, 30668573) could not be detached after 3 attempts.The physician retracted the coil and a new coil was switched to complete the surgery.There was no patient injury report.
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 3x6 orbit galaxy xtrasoft coil (640cx0306, 30668573) could not be detached after 3 attempts.The physician retracted the coil and a new coil was switched to complete the surgery.There was no patient injury report.No additional information is available.A non-sterile og cmplx xtrasoft coil 3x6 was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the support coil of the orbit galaxy was noted to be protruded from the introducer.No other damages or anomalies were observed on the device during the visual inspection.The device was inspected under microscopic magnification, and it was found that the introducer had a segment with the slit open, causing the support coil to protrude.Further inspection under magnification revealed that the coil component was severely stretched inside the introducer and still attached to the rest of the unit.The conditions described above precluded proper testing.The coil stretching, the introducer damage and the support coil protrusion did not allow the coil to be positioned to attempt the detachment.The issue documented that the coil could not be detached could not be tested for and there are no other ways to evaluate such failure.However, there is no indication that the issue reported in the complaint results from a defect inherently related to the device.It is possible that force may have inadvertently been applied during the maneuvering of the coil, which resulted in the support coil protruding condition.A manufacturing record evaluation was performed for the finished device 30668573 number, and no non-conformances related to the malfunction were identified.The damages noted on the returned components were not originally documented in the complaint and are suspected to be the result of the manipulation required during the coil removal.Coil stretching 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 issues from occurring.However, with the limited information available, the root cause of the coil stretching remains unknown, and does not seem to have contributed to the reported failure.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.The instructions for use (ifu) do contain the following recommendations: tensile or compressive stresses can result in forward movement of the infusion catheter, delivery tube movement, and movement of some portion of the coil which can lead to improper coil detachment.Prepare the syringe with sterile saline solution as instructed in the syringe instructions for use.If the syringe was previously used to detach a coil, confirm the maximum number of coil detachments or attempts is not exceeded.Do not exceed position 3, green zone, as this could cause the syringe to lose calibration.If position 3, green zone, has been exceeded, do not reuse the syringe for additional coil detachments.Maintain the pressure in position 3, green zone for approximately 3 seconds.Rapidly decreasing pressure indicates that the coil has been detached; however, detachment must be confirmed under fluoroscopy.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).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: OG CMPLX XTRASOFT COIL 3X6
• 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 ; 646591-7981
• MDR Report Key: 15094140
• Report Number: 3008114965-2022-00500
• Device Sequence Number: 5197251
• Product Code: KRD
• UDI-Device Identifier: 10886704030591
• UDI-Public: 10886704030591
• 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): 09/12/2022

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: 09/30/2023
• Device Model Number: 640CX0306
• Device Catalogue Number: 640CX0306
• Device Lot Number: 30668573
• 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: 07/05/2022
• Supplement Date Received by Manufacturer: 08/25/2022; 09/01/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 08/26/2022; 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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
• Patient Sex: Unknown