MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FREEFORM MINI 2MM X 6CM; CEREPAK FREEFORM MINI DETACHABLE COIL SYSTEM

Catalog Number MCR092060

Device Problems Difficult or Delayed Separation (4044); Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2023

Event Type  malfunction  

Event Description

As reported by the field, during a coil embolization, the manual break was used as the primary detachment approach.Six coils were used in this this case.Distal internal carotid artery (ica) with minimal tortuosity.The fourth coil, a freeform mini 2mm x 6cm (mcr092060, 31112710).Was advanced through an unspecified the microcatheter (mc) without any issue.When attempting to detach the coil, the suture broke when trying to pull back the pull wire.The coil did detach during this process.The end of the detachment was removed completely.The coil remained in the aneurysm.Same microcatheter was used during entire case.Another coil of the same size and lot number was used as the next coil without issues.No negative patient impact or significant patient delay.

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.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 company is seeking this information through the event investigation.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.

Manufacturer Narrative

Product complaint #(b)(4).Section b5: additional information received on 14-dec-2023 indicated that a headway duo 156cm microcatheter was used.There was no positioning difficulty in the aneurysm.There was damage to the embolic coil or any device component.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint #
=
> (b)(4).Based on the evaluation of the device received, the complaint description noted that the coil was implanted, and successfully detached after the doctors attempt to pull the wire.However, the pull-wire did break in the process which is not normal.As a result, the imdrf code has been updated to ¿difficult or delayed separation (a150302)¿.This code does not meet the us regulatory reporting criteria.Based on the product analysis, the pull wire ¿ was found broken near proximal inner tube.This finding meets us regulatory reporting criteria.Complaint conclusion: as reported by the field, during a coil embolization, the manual break was used as the primary detachment approach.Six coils were used in this this case.Distal internal carotid artery (ica) with minimal tortuosity.The fourth coil, a freeform mini 2mm x 6cm ((b)(6)) was advanced through an unspecified the microcatheter (mc) without any issue.When attempting to detach the coil, the suture broke when trying to pull back the pull wire.The coil did detach during this process.The end of the detachment was removed completely.The coil remained in the aneurysm.Same microcatheter was used during entire case.Another coil of the same size and lot number was used as the next coil without issues.No negative patient impact or significant patient delay.Additional information received on 14-dec-2023 indicated that a headway duo 156cm microcatheter was used.There was no positioning difficulty in the aneurysm.There was damage to the embolic coil or any device component.A non-sterile freeform mini 2mm x 6cm was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the embolic coil was found detached from the unit.No deformities were observed on the detachment tube.No defects were observed on the loop wire.No contamination was observed on the distal end.The pull wire broke at 19 cm from the proximal end and was found translated.The manual break was attempted at the proper location.The pull wire was removed from the delivery system, and difficulty was experienced while trying to extracted from the fused section.The kink feature was damaged during extraction.The outer diameter was measured, and it was found to be 0.001845 inches in the ablated area, and 0.002245 inches at the ptfe area.No visual defects were detected.There was no evidence of of ptfe delamination nor unintentional weld.The peek tube was dissected from the distal and proximal end.Residues of blood/contaminations were found inside the peek lumen at 10 cm from the distal end.No evidence of glue nor pebax reflow were found on the distal end of the peek tube.The distal and proximal outer diameters were measured and found within specifications.The crimp of the inner and outer tubes was inspected, and the inner tube slipped into the main delivery tube.No deformations were observed on the inner tube.The proximal joint was inspected.The welding location was visually inspected for correct welding/gluing and was found within specifications.The wire broke at 19 cm from the proximal end with respect to the welding location.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The issue reported regarding the suture breaking when attempting to pull back the pull wire was confirmed based on the broken condition of the pull wire.With the limited information available and the evidence obtained from the device inspection, there is no clear insight into the root cause and/or exact contributing factors that may have resulted in the observed failure mode.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damage from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.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.

• Brand Name: FREEFORM MINI 2MM X 6CM
• Type of Device: 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: 18266013
• MDR Text Key: 329722040
• Report Number: 3008114965-2023-00923
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704083016
• UDI-Public: 10886704083016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCR092060
• Device Lot Number: 31112710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEADWAY DUO 156CM MICROCATHETER; UNKNOWN MICROCATHETER