MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL10 4MM X 10CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF100410
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
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.Section d.2b: procode is krd/hcg.Section e.1: the name, phone and email address of the initial reporter are not available / reported.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 4mm x 10cm deltafill 10 was received contained in the decontamination pouch.Visual inspection was performed.The embolic coil was observed to be protruding from the introducer.The embolic coil component was inspected under the microscope.Under magnification, the coil was observed stretched at the proximal section.The embolic coil remains attached to the resistance heating (rh) coil and is still in one piece.The rh coil was not softened, an indication that the detachment process had not been initiated.The inner diameter (id) and outer diameter (od) of the introducer was measured and confirmed to be within specifications.The issue regarding a coil being unable to be pushed out of the introducer was confirmed since the damages noted in the coil prevented the ability to move the coil.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issues from occurring.According to the risk documentation, friction and difficulty to advance are potential issues that can occur during microcoil placement due to continuous saline flush not being established, which can result in coil stretching.The damages observed in the coil were not originally documented in the complaint; however, it could be the result of the difficulty experienced during the procedure that could not be replicated in the laboratory.There is no indication that the issue reported is a result of a defect inherently related to the device.A review of manufacturing documentation associated with this lot (30784433) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at final assembly for coil condition to prevent coil damage from leaving the facility.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) does contains the following recommendations: if unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.If unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw, and examine the delivery catheter system.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.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 the pre-op preparation for an endovascular embolization procedure, the complaint device, a 4mm x 10cm deltafill 10 (dlf100410 / 30784433) could not be pushed out of the introducer sheath.There was no report of any negative patient impact.On 21-feb-2024, additional information was received.Per the information, the coil has not yet been introduced into the microcatheter.No damage was visible on the device.Nothing was noted to be obstructing the introducer.The reported issue occurred when the coil was being inspected in saline; the issue occurred before connecting to the microcatheter.Excessive force had not been exerted on the device.The 4mm x 10cm deltafill 10 was returned for evaluation and analysis.Based on the result of the product analysis completed on 04-apr-2024, in which the embolic coil component was observed to be stretched at the proximal section, the reported issue meets usfda reporting criteria under 21 cfr 803 as a "malfunction.".

• Brand Name: DELTAFILL10 4MM X 10CM
• 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): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 19044790
• Report Number: 3008114965-2024-00375
• Device Sequence Number: 7242126
• Product Code: KRD
• UDI-Device Identifier: 10886704077053
• UDI-Public: 10886704077053
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 04/04/2024

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: 03/31/2025
• Device Catalogue Number: DLF100410
• Device Lot Number: 30784433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2022
• 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
• Patient Sex: Unknown