MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 4X6; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX0406
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
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.Section e1 ¿ initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Section h3 - 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 803 (and/or part 4, as applicable).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, an orbit galaxy xtrasoftcoil (640cx0406, 30790724) was being used as the second coil in the procedure.However, the coil couldn't be advanced nor retrieved by the physician.The physician pulled the coil and the unspecified microcatheter (mc) at the same time.After inspection, it turns out to be stretched.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3 and h10.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by the field, during a coil embolization, an orbit galaxy xtrasoftcoil (640cx0406, 30790724) was being used as the second coil in the procedure.However, the coil couldn't be advanced nor retrieved by the physician.The physician pulled the coil and the unspecified microcatheter (mc) at the same time.After inspection, it turns out to be stretched.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.No additional information is available.A non-sterile 4mm x 6cm orbit galaxy tdl complex fill was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and no apparent damage was observed.The device was inspected under magnification, and it was found that the coil was separated from the headpiece, and this remained attached to the gripper.The rest of the coil was not returned for evaluation.The gripper was found saturated with residues of dried blood.The issue documented in the complaint that there was resistance felt during the advancement of the coil through the microcatheter could not be evaluated through proper functional test since the device was returned incomplete.However, since the headpiece was still loaded into the introducer and mechanical detachment occurred, the primary failure mode appears to have been that the stretch-resistant fiber broke while the coil was being stretched, then the coil unraveled and pulled free from the headpiece.However, it is difficult to determine the exact contributing factors that may have resulted in the observed failure mode.Based on this, both allegations can be confirmed.According to the risk documentation, delivery tube / embolic coil not pushing through the microcatheter or encountering resistance in microcatheter is a potential failure mode that can occur during embolic coil placement due to 1) excessively tortuous anatomy, 2) incompatibility with microcatheter, 3) clot formation in the microcatheter.Coil stretching is a known potential issue associated with the use of this device.According to the risk documentation, coil stretching can occur during embolic coil placement due to excessive system manipulation, which may have been prompted by the resistance encountered during the procedure.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.It is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damages such as coil stretching from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.A manufacturing record evaluation was performed, and no non-conformance was found during the review.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contain the following precaution: ¿ if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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.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 4X6
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17060437
• Report Number: 3008114965-2023-00355
• Device Sequence Number: 8536715
• Product Code: KRD
• UDI-Device Identifier: 10886704030621
• UDI-Public: 10886704030621
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2023

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: 03/31/2024
• Device Model Number: 640CX0406
• Device Catalogue Number: 640CX0406
• Device Lot Number: 30790724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 06/15/2023; 08/14/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 06/16/2023; 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• 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: UNSPECIFIED MICROCATHETER
• Patient Sex: Unknown