MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 4MM X 15CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF180415
Medical Device Problem Codes	Material Rupture (1546); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported during the endovascular embolization procedure with the target lesion on the left internal iliac artery, the movement of the prowler select plus microcatheter in the 5fr impress® catheter (merit) was slow and it was difficult to push.The 4mm x 15cm deltafill 18 coil (dlf180415 / l17032) was the sixth coil used.It was inserted into the prowler select plus microcatheter.The coil was reported to be stuck and unable to move.Continuous flush was maintained through the microcatheter.In addition, the coil was exposed from the introducer sheath.The coil and the prowler select plus microcatheter were removed together.The coil became unraveled.The prowler select plus microcatheter was replaced with a competitor microcatheter and the coil was replaced with another g3 coil and the procedure was completed.There was no report of any patient adverse event or complication associated with the reported device issue.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l17032) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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.Coil unraveling / stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling for the device to prevent such issue from occurring.The embolic coil can become unraveled or stretched during attempts to withdraw it against resistance.With the information provided but without the complaint coil and the concomitant microcatheter available for analyses, the reported issue could not be confirmed through functional evaluation.The exact cause of the reported issue cannot be conclusively determined.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided and without the return of the complaint device.It is possible that when the coil became stuck in the prowler select plus microcatheter, some force was inadvertently applied to the device resulting in it becoming unraveled; the coil was reported to be exposed from the introducer sheath as the device became impeded in the microcatheter.The exact cause cannot be conclusively determined.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 4mm x 15cm deltafill 18 coil left the manufacturing facility with the embolic coil exposed from the introducer sheath and the coil in an unraveled condition.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.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 during the endovascular embolization procedure with the target lesion on the left internal iliac artery, the movement of the prowler select plus microcatheter in the 5fr impress® catheter (merit) was slow and it was difficult to push.The 4mm x 15cm deltafill 18 coil (dlf180415 / l17032) was the sixth coil used.It was inserted into the prowler select plus microcatheter.The coil was reported to be stuck and unable to move.Continuous flush was maintained through the microcatheter.In addition, the coil was exposed from the introducer sheath.The coil and the prowler select plus microcatheter were removed together.The coil became unraveled.The prowler select plus microcatheter was replaced with a competitor microcatheter and the coil was replaced with another g3 coil and the procedure was completed.There was no report of any patient adverse event or complication associated with the reported device issue.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 29 september 2021.[additional information]: the healthcare professional reported during the endovascular embolization procedure with the target lesion on the left internal iliac artery, the movement of the prowler select plus microcatheter in the 5fr impress® catheter (merit) was slow and it was difficult to push.The 4mm x 15cm deltafill 18 coil (dlf180415 / l17032) was the sixth coil used.It was inserted into the prowler select plus microcatheter.The coil was reported to be stuck and unable to move.Continuous flush was maintained through the microcatheter.In addition, the coil was exposed from the introducer sheath.The coil and the prowler select plus microcatheter were removed together.The coil became unraveled.The prowler select plus microcatheter was replaced with a competitor microcatheter and the coil was replaced with another g3 coil and the procedure was completed.There was no report of any patient adverse event or complication associated with the reported device issue.On 29 september 2021, additional information was provided.The information indicated that there was no resistance between the guidewire and the microcatheter when the target site was being accessed.There were no kinks on the microcatheter that may have contributed to the reported event.The same microcatheter was used with previous coils in the procedure.Coil entanglement with previously placed coils was not a contributing factor.When the complaint coil was removed, there was no additional damage noted on it.; another coil and another microcatheter were used as replacements to complete the procedure.Force was not applied during the attempt to resheath the coil.E.1: the initial reporter phone: (b)(6).The initial reporter email address is not available / reported.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: DELTAFILL18 4MM X 15CM
• 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: 12530340
• Report Number: 3008114965-2021-00449
• Device Sequence Number: 4307009
• Product Code: KRD
• UDI-Device Identifier: 10886704077206
• UDI-Public: 10886704077206
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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: 08/31/2022
• Device Model Number: DLF180415
• Device Catalogue Number: DLF180415
• Device Lot Number: L17032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5FR IMPRESS® CATHETER (MERIT).; MICROCATHETER.; RADIFOCUS® INTRODUCER SHEATH (TERUMO).; RUNTHROUGH® GUIDEWIRE (TERUMO).; Y- CONNECTOR (GOODTEC).