MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 2.5X2.5; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX2525
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
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 observed to be stretched, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.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.Complaint conclusion: as reported by the field, during a coil embolization of the anterior communicating artery (acom), the physician tried to deploy a 2.5x2.5 orbit galaxy xtrasoft (640cx2525, 30461376) through an echelon 10 microcatheter (mc).However, while advancing it midway through the catheter the doctor felt resistance.After a few tries, the doctor removed the coil and deployed competitive coils to complete there was no surgery delays due to the reported event.Additional information received indicated that it was not necessary to remove the microcatheter.Nothing was noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.No excessive force had been applied to the device.A non-sterile og cmplx xtra soft coil 2.5x2.5 was received inside of a pouch.Visual inspection of the returned device revealed that the support coil was protruding from the introducer.Under microscopic magnification, the embolic coil was observed to be stretched, but it was still attached to the headpiece.The headpiece was still inside the gripper.Due to the embolic coil being already stretched, the functional test could not be performed.A manufacturing record evaluation was performed for the finished device 30461376 number, and no non-conformances related to the malfunction were identified.The device was returned to cerenovus for further evaluation.Visual inspection of the returned device revealed that the support coil was protruding from the introducer, under microscopic magnification, the embolic coil was observed to be stretched, but it was still attached to the headpiece.The headpiece was still inside the gripper.The stretch on the embolic coil and the protruding condition noted on the support coil could have been caused when the embolic coil was tried to be advanced into the microcatheter and did not pass through midway.No contributing factors were identified from the device.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.The resistance encountered during the procedure could not be tested since the embolic coil was already stretched.However, the customer complaint can be confirmed based on the secondary damage encountered on the embolic coil.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) does contain the following precaution: 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.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failures and damages on the returned system.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.
Event or Problem Description
As reported by the field, during a coil embolization of the anterior communicating artery (acom), the physician tried to deploy a 2.5x2.5 orbit galaxy xtrasoft (640cx2525, 30461376) through an echelon 10 microcatheter (mc).However, while advancing it midway through the catheter the doctor felt resistance.After a few tries, the doctor removed the coil and deployed competitive coils to complete there was no surgery delays due to the reported event.Additional information received indicated that it was not necessary to remove the microcatheter.Nothing was noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.No excessive force had been applied to the device.Based on the product analysis of the device received, the embolic coil was observed to be stretched.

• Brand Name: OG CMPLX XTRASOFT COIL 2.5X2.5
• 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: 14073780
• Report Number: 3008114965-2022-00283
• Device Sequence Number: 6172347
• Product Code: KRD
• UDI-Device Identifier: 10886704030669
• UDI-Public: 10886704030669
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

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: 08/31/2022
• Device Model Number: 640CX2525
• Device Catalogue Number: 640CX2525
• Device Lot Number: 30461376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2020
• 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: ECHELON 10 MICROCATHETER
• Patient Sex: Unknown