MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FREEFORM MINI 2MM X 3CM; CEREPAK FREEFORM MINI DETACHABLE COIL SYSTEM

Catalog Number	MCR092030
Medical Device Problem Codes	Separation Failure (2547); Difficult to Advance (2920); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization, a freeform mini 2mm x 3cm coil (mcr092030, 31077163) was defective.Resistance was felt upon advancing the coiling into the body.Once the coil was advanced into the aneurysm, detachment error occurred, no detachment.Upon removing the coil from the aneurysm, the coil detached inside the sl-10 microcatheter (mc).Microcatheter and coil were removed from the patient and saved for analysis.Additional event information received on 03-may-2024 indicated that one cerepak coil was implanted, the rest were penumbra coils after this coil failed to detach properly.There was no positioning difficulty in the aneurysm.No attempts were made using the detachment handle, only manual break detachment.No damages were noted on the embolic coil or any device component.The vessel was not excessively tortuous or with acute bends.The event did not result in procedural delays.
Additional Manufacturer Narrative
Product complaint (b)(4) information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d2b ¿ procode: krd/hcg section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.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.
Additional Manufacturer Narrative
Product complaint (b)(4) the product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint #(b)(4).Complaint conclusion: as reported by the field, during a coil embolization, a freeform mini 2mm x 3cm coil (mcr092030, 31077163) was defective.Resistance was felt upon advancing the coiling into the body.Once the coil was advanced into the aneurysm, detachment error occurred, no detachment.Upon removing the coil from the aneurysm, the coil detached inside the sl-10 microcatheter (mc).Microcatheter and coil were removed from the patient and saved for analysis.Additional event information received on 03-may-2024 indicated that one cerepak coil was implanted, the rest were penumbra coils after this coil failed to detach properly.There was no positioning difficulty in the aneurysm.No attempts were made using the detachment handle, only manual break detachment.No damages were noted on the embolic coil or any device component.The vessel was not excessively tortuous or with acute bends.The event did not result in procedural delays.A non-sterile freeform mini 2mm x 3cm coil was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the embolic coil was detached from the delivery system.The manual break was attempted at the proper location, and the proximal end of the manual break was not returned.No damages were noted on the delivery system.A concomitant non-j&j microcatheter was received, and dried blood residues were noted in the luer hub and at the distal tip.The microcatheter was attempted to be flushed using a lab-sample syringe; however, strong resistance was encountered, and no water was leaking from the distal end of the microcatheter.A lab-sample guide wire was inserted at the distal end, and it could not passed from 47.5cm.The microcatheter was inspected under x-ray imaging, and the embolic coil was found detached at the distal end of the microcatheter.The microcatheter was dissected at the blocked area, and high amounts of compacted dried blood were found.A manufacturing record evaluation was performed for the finished device 31077163 number, and no non-conformances related to the malfunction were identified.Although the resistance felt while advancing the embolic coil through the microcatheter could not be duplicated due to the detachment condition of the embolic coil, this issue is confirmed based on the blocked condition of the microcatheter.It is suggested that this issue could be the result of an inadequate continuous saline flushing, since according to the risk documentation, resistance / friction between microcoil system and the microcatheter is a potential issue that can occur due to a continuous saline flush not maintained while introducing the detachable coil system.Additionally, the issue reported regarding the failure to detach the embolic coil and subsequently not detaching properly were confirmed based on the detachment attempts and the broken condition of the manual break.The issue reported that the coil detached inside the concomitant microcatheter was confirmed based on the condition in which the coil was received.It is suggested that the embolic coil could had been inadvertently detached when the delivery system and microcatheter were being manipulated for removal; however, with the limited information available, this remains unknown.It should be noted that product failure is multifactorial.A capa is currently investigating failure to detach.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following caution: if unusual friction is noticed during advancement or retraction of the detachable coil 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, flush the y-connector of the rhv with sterile saline and verify that fluid exits the proximal end of the introducer.After flushing, reinsert the introducer into the infusion catheter hub.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: FREEFORM MINI 2MM X 3CM
• Common Device Name: CEREPAK FREEFORM MINI 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: 19248979
• Report Number: 3008114965-2024-00468
• Device Sequence Number: 17972122
• Product Code: KRD
• UDI-Device Identifier: 10886704082996
• UDI-Public: 10886704082996
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2024

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: MCR092030
• Device Lot Number: 31077163
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 05/30/2024; 07/01/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/30/2024; 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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: SL-10 MICROCATHETER
• Patient Sex: Unknown