MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 8MM X 35CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF180835
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2019
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).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2019-01279.Complaint conclusion: as reported by a healthcare professional, during a endovascular aneurysm repair (evar) of an internal iliac artery, there was strong resistance felt between the distal end of a 8mm x 30cm micrusframe18 (mfr180830, s14023) and a 8mm x 35cm deltafill18 (dlf180835, s13515) with a coiling support microcatheter (mc).The complaint coils were not able to be delivered to the lesion.The physician flushed inside the microcatheter and the distal end of the coils but the same issue continued.The complaint coils were replaced with another coil (same catalog number) and the procedure was completed.Seven coils were used.Pictures were received.The customer states there is no additional information available.Pictured were received of the devices.Additional information received confirmed that while advancing the coil delivery systems through the concomitant microcatheter, the coil prematurely detached.A non-sterile unit deltafill18 8mm x 35cm was received inside of a pouch.The hub was inspected, and no damages was noted on it.The dpu was inspected and it was found kinked at 100 cm.Also, the marker band was found at 70 cm from distal end, and it was found within specification.The introducer was inspected, and it was found without damages.The re-sheating tool was inspected and it was found broken in two.The v-notch was inspected under microscope and it was found in normal good condition.The rh and the articulation joint were inspected under microscope and them were found without damage.As well as the rh was no heated.The embolic coil was inspected under microscope and it was found protruded from introducer in good normal conditions.The functional test could not be performed due during the analysis the embolic coil was found protruded from introducer.A manufacturing record evaluation was performed for the finished device s13515 number, and no non-conformances related to the reported complaint condition were identified.Based on the photos provided, it can be determined that the re-sheating tool is broken in two, the rh is not heated, and the embolic coil was noted protruded from the introducer and reddish material was observed on distal tip of the introducer.The complaint reported by the customer ¿detachable coil delivery system (dcs) - resistance/friction-during advancement with no loss of cerebral target position¿ could not be evaluated since during the analysis it was noted that the embolic coil is protruded from introducer.The kinked condition observed on the dpu and the protruded condition of the embolic coil it has been related with the costumer complaint and may have appeared to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.The complaint reported by the customer "coil - premature detachment-in microcatheter" was not able to be confirmed.The embolic coil was found attached to the device and the rh was found without damages on it.Neither the analysis nor the mre suggest that the failure reported by the costumer could be related to the manufacturing process.The instructions for use (ifu) states that continuous infusion of an appropriate flush solution is required for optimal performance and indicates that the flush should be verified in the event of resistance/friction during device advancement.Insufficient flush allows blood to back-flow into the microcatheter, which can cause resistance/friction.The exact cause of the reported events cannot be conclusively determined; however, it is possible that circumstances of the procedure and / or device manipulation / interaction may have contributed to the reported premature detachment.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.
Event or Problem Description
As reported by a healthcare professional, during a endovascular aneurysm repair (evar) of an internal iliac artery, there was strong resistance felt between the distal end of a 8mm x 30cm micrusframe18 (mfr180830, s14023) and a 8mm x 35cm deltafill18 (dlf180835, s13515) with a coiling support microcatheter (mc).The complaint coils were not able to be delivered to the lesion.The physician flushed inside the microcatheter and the distal end of the coils but the same issue continued.The complaint coils were replaced with another coil (same catalog number) and the procedure was completed.Seven coils were used.Pictures were received.The customer states there is no additional information available.Pictured were received of the devices.Additional information received confirmed that while advancing the coil delivery systems through the concomitant microcatheter, the coil prematurely detached.

• Brand Name: DELTAFILL18 8MM X 35CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 9473352
• Report Number: 3008114965-2019-01283
• Device Sequence Number: 2790380
• Product Code: KRD
• UDI-Device Identifier: 10886704077220
• UDI-Public: 10886704077220
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/03/2019

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: 02/29/2020
• Device Catalogue Number: DLF180835
• Device Lot Number: S13515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1