MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FREEFORM MINI 1MM X 4CM; CEREPAK FREEFORM MINI DETACHABLE COIL SYSTEM

Catalog Number MCR091040

Device Problems Fracture (1260); Separation Failure (2547)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

As reported by the field, during a coil embolization of a small anterior communicating artery (acom), a freeform mini 1mm x 4cm coil (mcr091040, 31045747) was being placed as the 4th coil, however, it failed to detach after 2 attempts with the handle.Manual detachment was attempted and pull wire did not move back after a 90-degree bend as per prep/delivery instructions (proximal outer hypotube slid off of pull wire).Hemostats were utilized on pull wire to try and perform manual detachment yet pull wire did not move with the portion clamped on snapping away.We advised the physician to then remove coil out of safety concerns and was retrieved to be sent for analysis.Two more coils were attempted and detached perfectly after defective one was removed.There were no patient complications, and the case was successful completed.The surgery was prolonged by 10 minutes due to the event, the delay was not clinically significant.Upon removal of coil to be sent for inspection, the coil was attempted to be re-sheathed on the back table.As the coil was about to enter the sheath after the detachment zone it deployed onto the table.No more friction than normal was reported by the assisting technologist during the re-sheathing.Additional information was received on 27-oct-2023 indicating that a stryker 45 sl-10 microcatheter was used.The microcatheter kicked back to base of aneurysm as end of coil was inserted and detachment point was met.There was no damage to the coil prior to detachment.During manual break proximal portion of outer hypotube came off without pull wire budging.Hemostats attempted then to manually detach and portion proximal to where they were clamped broke off.There was no vessel excessively tortuous or with acute bends.

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.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).Complaint conclusion: as reported by the field, during a coil embolization of a small anterior communicating artery (acom), a freeform mini 1mm x 4cm coil (mcr091040, 31045747) was being placed as the 4th coil, however, it failed to detach after 2 attempts with the handle.Manual detachment was attempted and pull wire did not move back after a 90-degree bend as per prep/delivery instructions (proximal outer hypotube slid off of pull wire).Hemostats were utilized on pull wire to try and perform manual detachment yet pull wire did not move with the portion clamped on snapping away.We advised the physician to then remove coil out of safety concerns and was retrieved to be sent for analysis.Two more coils were attempted and detached perfectly after defective one was removed.There were no patient complications, and the case was successful completed.The surgery was prolonged by 10 minutes due to the event, the delay was not clinically significant.Upon removal of coil to be sent for inspection, the coil was attempted to be re-sheathed on the back table.As the coil was about to enter the sheath after the detachment zone it deployed onto the table.No more friction than normal was reported by the assisting technologist during the re-sheathing.Additional information was received on 27-oct-2023 indicating that a stryker 45 sl-10 microcatheter was used.The microcatheter kicked back to base of aneurysm as end of coil was inserted and detachment point was met.There was no damage to the coil prior to detachment.During manual break proximal portion of outer hypotube came off without pull wire budging.Hemostats attempted then to manually detach and portion proximal to where they were clamped broke off.There was no vessel excessively tortuous or with acute bends.A non-sterile freeform mini 1mm x 4cm coil was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the embolic coil was noted to be detached from the delivery system, and shipped separately.Kinked conditions were noted on the embolic coil.No deformities were noted on the detachment tube.No defects were noted on the loop wire.No contamination was noted on the delivery system; however, dried blood and saline residues were found on the proximal key.The pull wire was noted to be broken at the edge of the inner tube; however, it is suspected that the wire moved/translated before shipping the device.The pull wire was translated, and it is suspected that this condition could had occurred during the removal of the coil.The manual break was attempted in the proper location.The pull wire was inspected.The kink feature was located at 6.5 cm from the distal end, with a height of 0.00740 inches, and a width of 0.01199 inches.The ablation pattern was found to be within specifications.The outer diameter (od) of the pull wire was found to be 0.00185 inches on the unablated area, and 0.00225 inches on the ablated area.One kinked condition was noted on the puller wire.No evidence of ptfe delamination nor unintentional weld was noted.The peek tube was dissected from the distal and proximal eds.No evidence of glue nor pebax reflow was noted on the distal end of the peek tube.The inner diameter (id) of the distal and proximal ends was measured and found within specifications.No obstructions in the lumen were noted.The crimp of the inner and outer tubes was inspected.The exposed length of the inner tube was found to be 4.1 cm.A deformation was found on the inner tube; however, it is suspected to be the result of the second or third pull with the handle during the attempts to detach the coil.The proximal joint was inspected, and the welding location welding/ gluing was found to be in good normal condition.The wire break with respect to approximately 8 cm 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 failure to detach the embolic coil could not be evaluated due to the detached condition of the embolic coil and the broken condition of the delivery system.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.The kinked condition of the embolic coil was not originally reported; the exact time of occurrence cannot be determined; however, it is suspected to be the result of the manipulation of the embolic coil once it was detached from the delivery system.Therefore, this condition is not considered a contributing factor to the failure encountered.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.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).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.

• Brand Name: FREEFORM MINI 1MM X 4CM
• 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: 18092644
• MDR Text Key: 327880601
• Report Number: 3008114965-2023-00816
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704082941
• UDI-Public: 10886704082941
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCR091040
• Device Lot Number: 31045747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2023
• 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: STRYKER 45 SL-10 MICROCATHETER
• Patient Age: 87 YR
• Patient Sex: Male