MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FRAME COIL 8X30; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CR0830
Medical Device Problem Codes	Failure to Advance (2524); Material Twisted/Bent (2981)
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
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.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 picture of the complaint device was received and visually analyzed.In the picture, only one section of the og tdl cmplx frame coil 8x30 could be noted.No damages could be noted on the device.The coil was not able to be seen in the picture.A manufacturing record evaluation (mre) was performed for the finished device 30628881 number, and no non-conformance's related to the malfunction were identified.The reported condition ¿coil - impeded-in introducer¿ could not be evaluated based on the pictures.The reported condition ¿coil - kinked/bent-prior to use¿ could not be evaluated based on the pictures.The mre suggests that the failure reported by the customer could not be related to the manufacturing process.No corrective action will be taken at this time.Further investigation will be performed once the device returns for analysis.Complaint trends are monitored on a monthly basis as part of the company post market surveillance.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 company is seeking this information through the event investigation.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 of the middle cerebral artery, the physician opened the package of an orbit galaxy coil (640cr0830, 30628881) and observed that the coil was impeded in introducer and could not be pushed out.The coil was also found to be kinked.The complaint device was not clinically used.The procedure was completed with another coil.
Additional Manufacturer Narrative
Product complaint #(b)(4).Section b5: additional information received indicated that there was no damage noted before removing the device from packaging or during removal from the package.The product was stored in the lab and handled according to the instructions for use (ifu).There was no damage noted to the packaging.The integrity of the sterile pouch was not compromised.The actual coil was not kinked (clarification pending).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
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 of the middle cerebral artery, the physician opened the package of an orbit galaxy coil (640cr0830, 30628881) and observed that the coil was impeded in introducer and could not be pushed out.The coil was also found to be kinked.The complaint device was not clinically used.The procedure was completed with another coil.Additional information received indicated that there was no damage noted before removing the device from packaging or during removal from the package.The product was stored in the lab and handled according to the instructions for use (ifu).There was no damage noted to the packaging.The integrity of the sterile pouch was not compromised.The actual coil was not kinked.A non-sterile og tdl cmplx frame coil 8x30 was received inside of a pouch.The device was inspected and vestamid was observed slightly bent at 151cm from the proximal end.The embolic coil was noted to be in good normal conditions, no kinks, stretched portions or non-concentric loops were observed.The embolic coil was pushed out of the introducer without noticeable issues, the manipulation did not cause any subsequent damage to the embolic coil.A manufacturing record evaluation (mre) was performed, and no non-conformances related to the complaint were found during the review.The device was returned to cerenovus for further evaluation.Visual inspection of the returned device revealed that vestamid was bent near the transition with the hypotube.This damage is consistent with the picture provided by the customer showing a slight bent near the transition with the hypotube, however the picture does not provide further evidence to assign a root cause.Under microscopic magnification, the coil was noted to be in good normal conditions inside the introducer, no kinks, stretched portions or non-concentric loops were observed.The concomitant microcatheter has an inner lumen of 0.0165 inches, which is compatible with the complaint device.Additionally, the concomitant microcatheter was not returned for evaluation and the information received indicates that no damages were noted on it.As such, no contributing factors to the issue reported were identified.The impeded condition of the returned device was tested, and the embolic coil advanced through the introducer without noticeable issues.When the embolic coil was pushed out of the introducer, it was inspected once again under microscope, and it was still intact.Therefore, the customer complaint was not confirmed.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) contains 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 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 events remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that 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 TDL CMPLX FRAME COIL 8X30
• 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: 12960024
• Report Number: 3008114965-2021-00641
• Device Sequence Number: 1792341
• Product Code: KRD
• UDI-Device Identifier: 10886704030454
• UDI-Public: 10886704030454
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2022

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: 06/30/2023
• Device Model Number: 640CR0830
• Device Catalogue Number: 640CR0830
• Device Lot Number: 30628881
• 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: 11/26/2021
• Supplement Date Received by Manufacturer: 12/21/2021; 02/15/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 01/12/2022; 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• 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
• Patient Sex: Unknown