MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FREEFORM 6MM X 20 CM; CEREPAK FREEFORM DETACHABLE COIL SYSTEM

Catalog Number	SCR120620
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization to the right carotid terminus, the physician had detachment issues with a uniform xl 10mm x 17.1 cm coil (fcx181017, 31243967).The mechanical detachment handle (mdh1, 102109430) did not break.He was able to get it to detach by pushing the coil pusher rapidly in and out.The next coil was a freeform 9mm x 25 cm (scr120925, 31173116), the handle detachment failed, and he then tried the manual break, this one detached.Then a freeform 6mm x 20 cm coil (scr120620, 31058141) was used.The handle failed and so did the manual break.He tried to make it detach by pushing the coil pusher in and out in hopes it would release.The physician then tried to remove the coil, while pulling it out of the aneurysm the coil detached in the echelon 10 microcatheter (mc).He was able to push the coil back into the aneurysm with a microwire.Additional event information was received on 16-apr-2024 indicating that the uniform xl 10mm x 17.1 cm coil was the first coil to be used.There was no resistance while pushing the coils through the microcatheter; there was no difficulty positioning the microcatheter into the aneurysm however there was difficulty getting up through the arch to get to the aneurysm.The vessel was very tortuous.There was no injury to the patient.The procedure was prolonged for approximately 15 to 20 minutes to the event, the delay was not clinically significant.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, race, and ethnicity was not reported.Section d2b ¿ procode: krd/hcg the device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 31058141 number, and no non-conformances related to the malfunction were identified.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.Premature detachment-in mc during removal is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.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.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.This is one of three products involved with the complaint and the associated manufacturer report numbers are 3008114965-2024-00439 and 3008114965-2024-00441.

• Brand Name: FREEFORM 6MM X 20 CM
• Common Device Name: CEREPAK FREEFORM DETACHABLE COIL SYSTEM
• 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 ; 3035526892
• MDR Report Key: 19201419
• Report Number: 3008114965-2024-00440
• Device Sequence Number: 18151413
• Product Code: KRD
• UDI-Device Identifier: 10886704083184
• UDI-Public: 10886704083184
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

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: 04/30/2026
• Device Catalogue Number: SCR120620
• Device Lot Number: 31058141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2023
• 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: ECHELON 10 MICROCATHETER
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Race: White