MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 6MM X 25CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF180625
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization for a pulmonary arteriovenous fistula, a deltafill18 6mm x 25cm coil (dlf180625, 30915596) was used as the third coil after two deltafill18 coils (8×35) (6×25) were implanted.The physician checked the electrical continuity.However, the energizing lamp on the detachable control box (dcb2) did not light up.The dcb was replaced with another box, but the same issue continued.The enpower control cable (ecb00018200, 30952244) was replaced with another cable, but the same issue continued.The physician judged this issue was caused by the complaint coil.The complaint coil was replaced with another deltafill18 coil (6×25) and the lamp was able to be illuminated with the replacement coil.Coil embolization was continued, and the procedure was completed after sixteen deltafill18 coils, two c stopper,s and four nester coils were used.There was no negative impact on the patient.A continuous flush was done.A leonismova microcatheter was used.
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: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.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).Updated sections on this medwatch: b4, b5, d9, e1, e2, e3, g3, g6, h2, h3 and h10.Section b5: additional information received indicated that the failure did not occur during pre-deployment electrical check.The same dcb and control cable were used successfully with the prior coils.The coil was still attached to the coil delivery system when removed from the patient.No damages on the coil were reported.There was no report of procedural delays due to the event.Section e1.Initial reporter phone: (b)(6).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by the field, during a coil embolization for a pulmonary arteriovenous fistula, a deltafill18 6mm x 25cm coil (dlf180625, 30915596) was used as the third coil after two deltafill18 coils (8×35) (6×25) were implanted.The physician checked the electrical continuity.However, the energizing lamp on the detachable control box (dcb2) did not light up.The dcb was replaced with another box, but the same issue continued.The enpower control cable (ecb00018200, 30952244) was replaced with another cable, but the same issue continued.The physician judged this issue was caused by the complaint coil.The complaint coil was replaced with another deltafill18 coil (6×25) and the lamp was able to be illuminated with the replacement coil.Coil embolization was continued, and the procedure was completed after sixteen deltafill18 coils, two c stopper,s and four nester coils were used.There was no negative impact on the patient.A continuous flush was done.A leonismova microcatheter was used.Additional information received indicated that the failure did not occur during pre-deployment electrical check.The same dcb and control cable were used successfully with the prior coils.The coil was still attached to the coil delivery system when removed from the patient.No damages on the coil were reported.There was no report of procedural delays due to the event.A non-sterile deltafill18 6mm x 25cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and the coil was found inside the introducer.A microscopical inspection revealed that the embolic coil was still attached to the articulating joint and in good normal condition.The distal outer sheath had not been softened, indicating that the resistance heating (rh) coil had not been heated and the detachment process was not initiated.The electrical resistance of the deltafill18 6mm x 25cm device was measured with a multimeter; however, no readings were observed.The issue reported that the energizing lamp on the detachable control box (dcb2) did not light up when the complaint coil was connected was confirmed based on the electrical discontinuity observed during testing.The issue was reported to have occurred intraoperatively, and the device has been removed from its packaging and handled in an unknown manner and environment; the complaint detailed that no failure occurred during pre-deployment electrical check nor inside the patient, thus, it is not likely that this issue resulted from a defect inherently related to the device.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.There is a control in place at the manufacturing site where all units are tested for electrical continuity test to ensure that it is acceptable.Review of the device history review (dhr) showed that all units in this lot (30915596) met the acceptance criteria for electrical continuity.This issue is being addressed through cerenovus quality systems, no capa activity is required at this time.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following instructions: ¿if a fault light is detected, the system ready light is not illuminated, or there is no detachment after two detachment attempts, replace the dcb unit.¿if detachment still does not occur, carefully withdraw the entire microcoil system and redeploy a new microcoil system.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: DELTAFILL18 6MM X 25CM
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15958523
• Report Number: 3008114965-2022-00819
• Device Sequence Number: 5574210
• Product Code: KRD
• UDI-Device Identifier: 10886704076933
• UDI-Public: 10886704076933
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2023

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: 09/30/2025
• Device Model Number: DLF180625
• Device Catalogue Number: DLF180625
• Device Lot Number: 30915596
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 12/29/2022; 09/13/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/17/2023; 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• 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: ENPOWER CONTROL CABLE; LEONISMOVA MICROCATHETER; UNK DETACHMENT CONTROL BOX
• Patient Sex: Unknown