MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 4X12; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CF0412
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization, the physician filled aneurysm with a 4x12 orbit galaxy coil (640cf0412, 30530425), but the shape of coil was not ideal.The doctor attempted to retract the coil to adjust, however, the coil was found to be impeded in a non j&j microcatheter (mc) and could not be retracted.The physician removed the coil with microcatheter together.A new coil was switched to complete the surgery.There was no patient injury report.Additional information received indicated that there was no damage to the coil.No excessive force was applied to the device.The shape of the coil was not different than expected.The coil did not fail to conform to aneurysm wall.The coil was not found to be herniated or protruded out of the aneurysm.Based on the analysis of the device received, the embolic coil was found damaged.
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 was found damaged, the findings meet regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone: (b)(6).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 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.Complaint conclusion: as reported by the field, during a coil embolization, the physician filled aneurysm with a 4x12 orbit galaxy coil (640cf0412, 30530425), but the shape of coil was not ideal.The doctor attempted to retract the coil to adjust, however, the coil was found to be impeded in a non j&j microcatheter (mc) and could not be retracted.The physician removed the coil with microcatheter together.A new coil was switched to complete the surgery.There was no patient injury report.Additional information received indicated that there was no damage to the coil.No excessive force was applied to the device.The shape of the coil was not different than expected.The coil did not fail to conform to aneurysm wall.The coil was not found to be herniated or protruded out of the aneurysm.A non sterile orbit galaxy complex fill 4mm x 12cm coil was received contained in a decontamination pouch.Upon arrival, visual inspection was performed, and the embolic coil component was found to be detached from the delivery wire.The delivery wire was noted to be protruding from the introducer.Additionally, two kinks were noted on the delivery wire at 43 cm and 103 cm from the proximal end.Microscopic inspection was performed, and the gripper component was observed to be twisted as it had been rotated.The coil component was found to be damaged as a focal separation of the adjacent loops was found.The introducer component was confirmed to be within specification for the outer diameter (od) and the distal inner diameter (id).A manufacturing record evaluation was performed, and no non conformances related to the complaint were found during the review.The impeded condition of the coil in the microcatheter could not be evaluated through functional test since the conditions noted during the visual and microscopic inspection precluded further manipulation of the device.However, such damages could be secondary to the issue encountered during the procedure.Coil damage 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.The damaged condition of the embolic coil was not originally reported in the complaint and is suggested that it may have appeared during the handling of the device at the time of the procedure.It is possible that while trying to advance the coil through the microcatheter, excessive manipulation was required, which resulted in the coil damage, introducer and delivery wire kinking, and gripper twisting.It is unknown if continuous flush was done, without an adequate flush, issues such as resistance between the coil and the microcatheter can arise, resulting in excessive force applied and subsequent component damage.The coil detachment was not originally reported in the complaint and the exact contributing factors that could have led to this issue could not be determined.It is possible that the coil may have popped out during the post operative handling as a result of the gripper twisting, however, this cannot be conclusively determined.The customer complaint was confirmed.However, there is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.Is possible that other procedural factors, that cannot be determined during analysis, may have contributed to the failure mode encountered.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: never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.If friction is noted with any subsequent detachable coil system, carefully examine the detachable coil system and the infusion catheter for possible damage.Replace both if necessary.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: OG TDL CMPLX FILL COIL 4X12
• 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: 15392477
• Report Number: 3008114965-2022-00596
• Device Sequence Number: 14977949
• Product Code: KRD
• UDI-Device Identifier: 10886704030270
• UDI-Public: 10886704030270
• 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): 09/09/2022

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: 01/31/2023
• Device Model Number: 640CF0412
• Device Catalogue Number: 640CF0412
• Device Lot Number: 30530425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2021
• 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: NON J&J MICROCATHETER
• Patient Sex: Unknown