MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3X4; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX0304
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a col embolization, the physician used an excelsior sl10 microcatheter to cannulate the aneurysm and deploy a 3x4 orbit galaxy xtrasoft coil (640cx0304, 30261288).While advancing the coil through the sl10 microcatheter (mc), the physician noticed a resistance in the midway of the mc.After a few attempts, he withdrew the coil through the mc without any problems and deployed successfully a competitor¿s coil with the same mc.The procedure was successfully completed and there was no patient injury.The event did not result in a loss of cerebral target position.There was no damage to the mc upon removal from the patient.The product complaint was not damaged in any way at any time.Nothing was noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.No excessive force was applied to the device.Based on the device analysis of the device received, the embolic coil is severely stretched.
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 noted as being stretched, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.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 col embolization, the physician used an excelsior sl10 microcatheter to cannulate the aneurysm and deploy a 3x4 orbit galaxy xtrasoft coil (640cx0304, 30261288).While advancing the coil through the sl10 microcatheter (mc), the physician noticed a resistance in the midway of the mc.After a few attempts, he withdrew the coil through the mc without any problems and deployed successfully a competitor¿s coil with the same mc.The procedure was successfully completed and there was no patient injury.The event did not result in a loss of cerebral target position.There was no damage to the mc upon removal from the patient.The product complaint was not damaged in any way at any time.Nothing was noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.No excessive force was applied to the device.A non-sterile unit og cmplx xtrasoft coil 3x4 was received inside of a pouch.The device was visually inspected, and it was noted that the embolic coil is stretched and entangled with the hypo-tube.No other damages or anomalies were observed during the visual analysis.The og cmplx xtrasoft coil 3x4 was inspected under microscope, and it was found that the embolic coil is severely stretched and entangled with the hypo-tube.A functional test could not be performed due to the conditions above noted.A manufacturing record evaluation (mre) was performed for the finished device 30261288 number, and no non-conformance's related to the reported complaint condition were identified.Cerenovus conducted a visual inspection and microscopic inspection.The functional test could not be performed due to the conditions in which the device was returned.During the visual and microscopic analysis of the device it was noted that the embolic coil is severely stretched and entangled with the hypo-tube, this condition may contribute to the customer experience at the procedure time regarding an impeded condition in microcatheter.Based on these findings, the customer complaint was confirmed.During the microscopic inspection it was found that the embolic coil is in good normal conditions.A manufacturing record evaluation was performed, and no non-conformance's related to the reported complaint condition were identified.It should be noted that product failure is multifactorial.The instructions for use do contain the following precautions: 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 unusual friction is noted within the infusion catheter, remove the detachable coil system.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.Assignment of root cause for the event 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.

• Brand Name: OG CMPLX XTRASOFT COIL 3X4
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13017588
• Report Number: 3008114965-2021-00683
• Device Sequence Number: 5188327
• Product Code: KRD
• UDI-Device Identifier: 10886704030584
• UDI-Public: 10886704030584
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2021

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: 06/30/2021
• Device Model Number: 640CX0304
• Device Catalogue Number: 640CX0304
• Device Lot Number: 30261288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2019
• 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: EXCELSIOR SL10 MICROCATHETER
• Patient Sex: Unknown