MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 4X8; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CX0408
Medical Device Problem Codes	Positioning Failure (1158); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization to the c5 segment of internal carotid artery, when partial of an og cmplx xtrasoft coil 4x8 was filled in the aneurysm, the unspecified microcatheter (mc) should be repositioning, physician tried to retract the coil into introducer sheath, but the coil couldn¿t be withdrawn because of the zip stuck.The doctor removed the coil from patient and switched a new coil to complete the surgery.The microcatheter was not replaced.The procedure was prolonged about 10 minutes.Additional information was received on 01-nov-2024 indicating that there was no damage noted on the sheath introducer.The delivery wire or coil was not noted to be protruding from the introducer.There was no resistance at any time during advancement of the coil through the mc.Neck remodeling was utilized with a stent.The coil was not positioned at a relative sharp angle to the microcatheter.It was not necessary to remove the microcatheter.Based on the product analysis of the device received, the embolic coil is kinked.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil is kinked, the findings meet us regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d2b ¿ procode: krd/hcg.Section e1.Initial reporter phone: (b)(6).One of the photos accompanying the complaint file showed the introducer with multiple kinked conditions near to the zipper.No further damages could be noted.The coil was not shown in the picture.A non-sterile orbit galaxy cmplx xtrasoft coil 4x8 was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and it was noted that the coil and support coil were protruded from the introducer.Several torqued and bent conditions were noted on the proximal end of the introducer next to the zipper.The coil was inspected under magnification, and one (1) kinked condition was noted.The coil was noted to still be attached to the gripper.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The issue reported regarding the zip being stuck was confirmed since the damages noted in the introducer prevented the device from being rezipped.According to the risk documentation, the inability to withdraw the delivery tube / embolic coil through the microcatheter, and / or the delivery tube/ embolic coil encountering resistance in the microcatheter are potential issues that can occur during the retrieval of the embolic coil due to an excessively tortuous anatomy, incompatibility with the microcatheter, and / or clot formation.The issue regarding the difficulty to reposition the device could not be evaluated since the reported issue is specific to the patient and procedure at the time of occurrence, and cannot be replicated in the laboratory.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.There could be other factors that may have contributed to these issues encountered during the procedure.There is no indication that the issues reported in the complaint resulted from a defect inherently related to the device.The kinked condition found on the coil was not originally reported; the exact time of occurrence cannot be determined; therefore, this condition is not considered relevant to the failures reported.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 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.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) do contain the following recommendation: ¿ firmly hold the exposed portion of the delivery tube with one hand.Simultaneously, grasp the introducer just distal to the stopper with the other hand and slide the coil introducer proximally along the delivery tube until the coil introducer has stripped itself from the delivery tube up to the zipper.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.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.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.

• Brand Name: OG CMPLX XTRASOFT COIL 4X8
• 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): CERENOVUS 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: 18484179
• Report Number: 3008114965-2024-00027
• Device Sequence Number: 21101737
• Product Code: KRD
• UDI-Device Identifier: 10886704030638
• UDI-Public: 10886704030638
• 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
• Report Date (Section B): 01/10/2024

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: 02/28/2025
• Device Catalogue Number: 640CX0408
• Device Lot Number: 31028741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2023
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 65 KG