MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FREEFORM 4MM X 7 CM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	SCR120407
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
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 email address is not available / reported.Section h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (31149189) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, 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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 an endovascular embolization procedure, two coils ¿ a 4mm x 10cm cerepak freeform (scr120410 / 31140705) and a 4mm x 7cm cerepak freeform (scr120407 / 31149189) would not detach once deployed in a cerebral aneurysm.The coils were successfully removed without any negative impact to the patient.The procedure was reported as successfully completed with the patient successfully treated with different coils.There was no delay in the procedure as a result of the reported issues.On 09-jul-2024, additional information was received.Per the information, the location of the target aneurysm was the left middle cerebral artery (mca).The attempts to detach the coils were made using the detachment handle as well as mechanical break.The catalog and lot number of the detachment handle used was mdh1 / 102109430.The coils were not stretched when they were removed.Both coils were still attached to their respective delivery systems when they were removed.The microcatheter used was a prowler select lpes (mc1755s2u / 30967330).The information indicated that the coils were not replaced with coils from the same product codes or different brands.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 18-jul-2024.A supplemental 3500a report will be submitted once the product investigation has been completed.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 4mm x 7cm cerepak freeform was received contained in the decontamination pouch.Visual inspection was performed.The embolic coil was observed not attached to the delivery system.The manual break was attempted, and 11.5 cm of the puller wire were exposed.The embolic coil was not returned for evaluation.Microscopic inspection performed on the distal end of the device showed no damages on the support coil.The issue reported regarding the failure to detach the embolic coil was not confirmed due to the broken condition of the manual break and detached condition of the embolic coil.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The appearance of the returned device does not suggest that it was subjected to excessive force to overcome the friction with the microcatheter.A review of manufacturing documentation associated with this lot (31149189) 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.The instructions for use (ifu) provides the following recommendations for the manual break use: 1.Locate the manual break indicator (mbi) markers approximately 20cm from the proximal end of the device.2.Using your thumb & forefinger, grip the delivery pusher with one hand precisely at the center of each of the mbi markers.3.Bend the proximal end of the pusher between the mbi markers approximately 90 degrees or until the tube snaps.If needed, continue bending and straightening until the tube separates and exposes the internal pull-wire.4.Ensure the proximal portion of the delivery tube is in line with the remaining tube.While holding the distal end, pull the proximal end approximately 2-3cm to release the coil.Note: if it is determined that the coil will not be detached, remove it from the microcatheter as outlined in the following section.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.

• Brand Name: FREEFORM 4MM X 7 CM
• 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.; calle circuito int norte 1820; parque industrial salvacar; juarez 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 19707391
• Report Number: 3008114965-2024-00645
• Device Sequence Number: 15323432
• Product Code: KRD
• UDI-Device Identifier: 10886704083115
• UDI-Public: (01)10886704083115(11)230911(17)260831(10)31149189
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K220040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2024

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: 08/31/2026
• Device Catalogue Number: SCR120407
• Device Lot Number: 31149189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 07/18/2024; 07/25/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/18/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2023
• 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: MC 0165", 150 CM, STRAIGHT, US; MECHANICAL DETACHMENT HANDLE
• Patient Sex: Unknown