MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL10 6MM X 12CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF100612
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.Based on the analysis of the device received, the embolic coil was found to be stretched and kinked.The findings meet regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/ hcg.This information was not provided in the reported event or available at the time of report submission.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 deltafill 10 6mm x 12cm coil (dlf100612, 30474387) was checked as usual, and nothing conspicuous was found.When trying to pull the coil back into the system, a defect was found in the re-sheeting system.Since the wire of the coil was now outside the system extraluminally, it was no longer possible to pull the coil back into the system and thus to use it.There was surgery delay by 10 minutes due to the reported event.The procedure was successfully completed.Additional information received indicated that there was no difficulty removing the device from packaging.There was no excessive force applied.A non-sterile deltafill10 6mm x 12cm was received inside of a pouch for analysis.The device was inspected upon arrival and a kink was found at 50 inches from the proximal end.Additionally embolic coil was found to be protrudin from the introducer.The device was inspected under a microscope, introducer was observed split where embolic coil was protruding from it.Additionally, embolic coil was found to be stretched and kinked.Due to these damages zipping functionality could not be tested.A manufacturing record evaluation was performed, and no non-conformances related to the complaint were found during the review.The product was returned to cerenovus for evaluation.Visual and microscopic inspection of the returned deltafill 10 6mm x 12cm revealed that the core wire was kinked at 50 inches from the proximal end.Introducer was found to be split and embolic coil was protruding from it.Embolic coil was found to be kinked and stretched.The protruding condition above noted could have been inadvertently caused by pre-operative handling, however this cannot be conclusively determined.Damages described are consistent with the reported event, therefore, customer complaint was confirmed.A manufacturing record evaluation was performed, and no non-conformance related to the complaint were found during the review.It should be noted that failure could be caused by multiple factors, however the instructions for use (ifu) contains the following precautions: do not pull the dpu wire back too far since it may cause a softer section of the dpu wire to become exposed.An arm¿s length pull should re-sheath the coil.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 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.
Event or Problem Description
As reported by the field, during a coil embolization, a deltafill 10 6mm x 12cm coil (dlf100612, 30474387) was checked as usual, and nothing conspicuous was found.When trying to pull the coil back into the system, a defect was found in the re-sheeting system.Since the wire of the coil was now outside the system extraluminally, it was no longer possible to pull the coil back into the system and thus to use it.There was surgery delay by 10 minutes due to the reported event.The procedure was successfully completed.Additional information received indicated that there was no difficulty removing the device from the packaging.There was no excessive force applied.Based on the analysis of the device received, the embolic coil was found to be stretched and kinked.

• Brand Name: DELTAFILL10 6MM X 12CM
• 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: 13636992
• Report Number: 3008114965-2022-00160
• Device Sequence Number: 17443719
• Product Code: KRD
• UDI-Device Identifier: 10886704077091
• UDI-Public: 10886704077091
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2022

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: 10/31/2023
• Device Model Number: DLF100612
• Device Catalogue Number: DLF100612
• Device Lot Number: 30474387
• 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: 02/28/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2020
• 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