MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL G2 COMPLEX XTRASOFT COIL 3X6; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	641CX0306
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
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.Procode: krd/hcg.Lot: the lot number was not reported.Initial reporter phone: (b)(6).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.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, a 3x6 orbit galaxy enpower xtrasoft coil (641cx0306, unknown lot) became stretched inside the unspecified microcatheter (mc) while deploying in the aneurysm.The surgery was delayed due to the reported event by 10 minutes.The microcatheter was removed from the site.The procedure was successfully completed.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Additional information received indicated that there was no resistance/friction encountered while advancing the coil.The complaint coil was not implanted.There was resistance while deploying the coil in target site.The mc being used was an echelon 10.The event did result in loss of cerebral target position.The target vessel/site being treated was the right internal carotid artery (ica).Prior to the complaint coil, other coils had been able to be advanced through the same microcatheter.There was no blood flow restriction/reduction as a result of the event.An adequate flush was maintained through the devices.No excessive force was used at any time with the device.The physician did not feel the prolongation of the procedure was clinically significant.
Additional Manufacturer Narrative
Product complaint#: (b)(4).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, a 3x6 orbit galaxy enpower xtrasoft coil (641cx0306, l12115) became stretched inside the unspecified microcatheter (mc) while deploying in the aneurysm.The surgery was delayed due to the reported event by 10 minutes.The microcatheter was removed from the site.The procedure was successfully completed.There was no patient injury reported.Additional information received indicated that there was no resistance/friction encountered while advancing the coil.The complaint coil was not implanted.There was resistance while deploying the coil in target site.The mc being used was an echelon 10.The event did result in loss of cerebral target position.The target vessel/site being treated was the right internal carotid artery (ica).Prior to the complaint coil, other coils had been able to be advanced through the same microcatheter.There was no blood flow restriction/reduction as a result of the event.An adequate flush was maintained through the devices.No excessive force was used at any time with the device.The physician did not feel the prolongation of the procedure was clinically significant.A non-sterile g2 complex xtra soft coil 3x6 was received inside of a pouch, revelated that the core wire was observed to be kinked at 7.5 inches from the proximal end.Under microscopic magnification, the embolic coil was noted to be stretched inside the introducer, which is consistent with the issue noted in the event description.The rest of the components were found to be in good condition.The functional test could not be performed due to the damages observed in the core wire and the embolic coil.A manufacturing record evaluation was performed for the finished device l12115 number, and no non-conformances related to the malfunction were identified.The device was returned to cerenovus for further evaluation.Upon arrival, the core wire was observed to be kinked at 7.5 inches from the proximal end.Under microscopic inspection, the embolic coil was noted to be stretched inside the introducer, which is consistent with the issue noted in the event description.The rest of the components were found to be in good condition.The concomitant microcatheter (echelon 10) has an inner lumen of 0.017 in (0.4318 mm), which is compatible with the complaint coil.However, the products used as a system with the complaint device were noted to be not available.As such, no further evaluation could be conducted.The customer complaint was confirmed based on the finding observed.The issue might have occurred due to the resistance encountered while deploying the coil in the target site, no contributing factors could be identified from the components returned.A manufacturing record evaluation was performed, and no non-conformances related to the complaint were 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 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 repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.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: G2 COMPLEX XTRASOFT COIL 3X6
• 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. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13333224
• Report Number: 3008114965-2022-00050
• Device Sequence Number: 1647034
• Product Code: KRD
• UDI-Device Identifier: 10878528008948
• UDI-Public: 10878528008948
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K120686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2022

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: 03/31/2023
• Device Model Number: 641CX0306
• Device Catalogue Number: 641CX0306
• Device Lot Number: L12115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 01/27/2022; 03/24/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 02/15/2022; 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2018
• 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.; UNSPECIFIED MICROCATHETER.
• Patient Sex: Unknown