MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	DLF180733
Medical Device Problem Codes	Positioning Problem (3009); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4) information regarding patient identifier, date of birth, age, sex, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section e.1: the initial reporter phone is not available / reported.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (1352562s) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information available and without the product available for analysis, the reported issue documented in the complaint could not be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and / or device manipulation / interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered later.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.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 johnson & johnson medtech, or its employees that the report constitutes an admission that the product, johnson & johnson medtech, 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.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 coil embolization of the internal iliac artery prior to an endovascular aneurysm repair (evar) to treat an abdominal aortic aneurysm, devices were used in accordance with the instructions for use (ifus).After approaching the right internal iliac artery from the contralateral side, using 6fr destination® guiding sheath (terumo interventional), a 5fr diagnostic catheter (unspecified brand), and a breakthrough¿ microcatheter (boston scientific), the embolization of the inferior gluteal artery was initiated.The inferior gluteal artery was embolized using an embold¿ detachable coil system (boston scientific) and a 7mm x 33cm deltafill 18 (dlf180733) and was completed without any issue.Then the superior gluteal artery embolization was initiated.A 6mm embold coil was placed as the first coil.A 9mm x 35cm deltafill 18 (dlf180935 / 1182524s) was used as the second coil.During coil insertion, the breakthrough microcatheter dislodged from the superior gluteal artery.During the coil retrieval, the sheath tore, and re-sheathing was not possible.The 9mm x 35cm deltafill 18 (dlf180935) was replaced with another 9mm x 35cm deltafill 18 (dlf180935) from the same lot (1182524s).It was reported that during the attempt to insert this replacement 9mm x 35cm deltafill 18 coil into the microcatheter, the sheath was found to be already torn, exposing the delivery wire from the middle of the sheath, and the coil could not be advanced.Re-sheath was attempted, but it was unsuccessful.The use of the replacement 9mm x 35cm deltafill 18 coil was given up.¿since the same size coil was unavailable, the 7mm x 33cm deltafill 18 (dlf180733 / 1352562s) was used.¿ during the coil insertion, the coil accidentally entered a side branch of the superior gluteal artery.The coil was pushed and pulled several times to adjust the coil position in the superior gluteal artery.During this process, there was a feeling that the coil broke with a "snap," and upon withdrawing the delivery wire, the coil separated from the coil detachment part.Most of the coil remained inside the microcatheter, so the coil was successfully removed from the patient¿s body with the microcatheter.No residual coil was left in the patient¿s body.Another coil of the same size was not available, resulting in the use of a 6mm x 25cm deltafill 18 (dlf180625).This coil was placed without any problems.The embolization of the internal iliac artery was successfully completed.There was no negative impact on the patient.On 27-aug-2025, additional information was received.The information indicated that the 7mm x 33cm deltafill 18 (dlf180733) did not become separated into two or more pieces.The coil separated at the detachment point.The reported issue did not result in reduction / restriction of blood flow in the parent vessel.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 04-sep-2025.[additional information]: on 04-sep-2025, additional information was received.Per the information, related to the coil condition, whether it was stretched when it was removed, ¿the disconnected part has been checked, but whether the coil has stretched has not been confirmed and is unknown.¿ the original breakthrough microcatheter used to deliver the replacement 6mm x 25cm deltafill 18 (dlf180625) coil.The reported issue did not result in any clinically significant delay in the procedure.Updated sections: b.4, g.3, g.6, h.2, and h.11.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.

• Brand Name: DELTAFILL
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 949788-2078
• MDR Report Key: 22965494
• Report Number: 3008114965-2025-00900
• Device Sequence Number: 9125147
• Product Code: KRD
• UDI-Device Identifier: 10886704076940
• UDI-Public: (01)10886704076940(17)280630(10)1352562S
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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 Catalogue Number: DLF180733
• Device Lot Number: 1352562S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2025
• 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: 5FR DIAGNOSTIC CATHETER (UNSPECIFIED BRAND).; 6FR DESTINATION® (TERUMO INTERVENTIONAL).; BREAKTHROUGH¿ MICROCATHETER (BOSTON SCIENTIFIC).; EMBOLD¿ DETACHABLE COIL SYSTEM (BOSTON SCIENTIFIC).
• Patient Sex: Unknown