MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3.5X9; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX3509
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref no: pc- (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.Procode is krd/hcg.The initial reporter phone: (b)(6) the initial reporter email address was not available/reported.Conclusion: the healthcare professional reported that during a stent-assisted aneurysm embolization procedure performed under general anesthesia, the echelon¿ 10 microcatheter (medtronic) was placed in the target position.The physician tried to push the complaint coil, a 3.5mm x 9cm orbit galaxy complex xtrasoft (640cx3509 / 30517515) into the microcatheter but observed that the coil was impeded in the microcatheter hub.The coil was retracted and replaced to complete the procedure.There was no report of patient injury or complication.On (b)(6) 2021.Additional information was received.The information indicated that the echelon 10 microcatheter was not removed when the coil was replaced.There was no damage observed on the complaint device at any time.Nothing was noted to be obstructing the microcatheter; a continuous flush was maintained through the microcatheter.Excessive force was not applied to the device.On (b)(6) 2022.Confirmation was provided by the cerenovus sales representative that the complaint coil was impeded in the concomitant microcatheter.Stryker electrolytic coil was also used in the procedure.The physician did not notice any damage.No additional information could be obtained.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 3.5mm x 9cm orbit galaxy complex xtrasoft was received.Visual inspection was performed.During the visual inspection of the device, the distal portion of the hypotube was found to be detached at 61 inches from the proximal end and it was not returned with the rest of the device, neither the embolic coil component was returned for evaluation.The hypotube was observed to be bent at 33 and 56 inches from the proximal end.Additionally, a twisted portion of the introducer with the support coil inside was observed at 59 inches from the proximal end of the hypotube.It was noticed that the outer diameter (od) of the damaged portion of the introducer was reduced in comparison to undamaged portions of it, suggesting that the introducer was elongated with the support coil inside and eventually broke off.The remaining portion of the support coil was removed from the introducer, it was inspected under microscope, and it was observed elongated.The damages described above suggest excessive manipulation due to the impeded condition reported.However; an additional follow up was performed, and the response obtained indicated that the damage present on the returned device was not noticed by the physician.It could not be clarified if the damages occurred during or after the procedure; moreover, the location at which the support coil and introducer broke off would suggest that the coil got impeded at the mid-shaft of the microcatheter, which might have prompted the user to grasp the device from that length to retrieve the device.Therefore, since the complaint documented that the coil was impeded in the hub of the microcatheter, it is possible that these damages occurred during the post-operative handling of the device and could not have contributed to the encountered issue.Due to the condition observed on the support coil and introducer components, and since the embolic coil was not returned, no further testing could be performed, and the customer complaint could not be evaluated.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.A review of manufacturing documentation associated with this lot (30517515) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during a stent-assisted aneurysm embolization procedure performed under general anesthesia, the echelon¿ 10 microcatheter (medtronic) was placed in the target position.The physician tried to push the complaint coil, a 3.5mm x 9cm orbit galaxy complex xtrasoft (640cx3509 / 30517515) into the microcatheter but observed that the coil was impeded in the microcatheter hub.The coil was retracted and replaced to complete the procedure.There was no report of patient injury or complication.On (b)(6) 2021.Additional information was received.The information indicated that the echelon 10 microcatheter was not removed when the coil was replaced.There was no damage observed on the complaint device at any time.Nothing was noted to be obstructing the microcatheter; a continuous flush was maintained through the microcatheter.Excessive force was not applied to the device.On (b)(6) 2022.Confirmation was provided by the cerenovus sales representative that the complaint coil was impeded in the concomitant microcatheter.Stryker electrolytic coil was also used in the procedure.The physician did not notice any damage.No additional information could be obtained.The complaint device was returned for analysis.During the visual inspection, it was noted that the distal portion of the hypotube was detached at 61 inches from the proximal end and it was not returned with the rest of the complaint device.Based on the result of the product analysis completed on (b)(6) 2022.The event has been deemed reportable as a "malfunction.".

• Brand Name: OG CMPLX XTRASOFT COIL 3.5X9
• 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: 14324916
• Report Number: 3008114965-2022-00327
• Device Sequence Number: 14757511
• Product Code: KRD
• UDI-Device Identifier: 10886704030690
• UDI-Public: 10886704030690
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2022

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: 12/31/2022
• Device Model Number: 640CX3509
• Device Catalogue Number: 640CX3509
• Device Lot Number: 30517515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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: ECHELON¿ 10 MICROCATHETER (MEDTRONIC)
• Patient Age: 56 YR
• Patient Sex: Male