MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 7MM X 30CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number MFR100730

Device Problems Failure to Advance (2524); Material Twisted/Bent (2981)

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

Event Date 08/31/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during an endovascular embolization procedure, the complaint coil, a 7mm x 30cm micrusframe 10 (mfr100730 / 30757481) got stuck several times in the microcatheter (unspecified brand).The coil could not be positioned with stability inside the fistula.It was reported that the coil ¿looked skew.¿ there was no report of any negative patient impact.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Section d.2b: procode is krd/hcg.Section h.3: 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.A review of manufacturing documentation associated with this lot (30757481) 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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 11- sep-2023.[additional information]: on 11-sep-2023, additional information was received.The information indicated that the location of the target vessel / location of the fistula is not available.Information related to the microcatheter used is also not available.A continuous flush had been maintained through the microcatheter.There was no resistance between the guidewire and the microcatheter when the target site was being accessed.There was no resistance at any time during the advancement of the coil through the microcatheter.There were no kinks on the microcatheter that may have contributed to the reported issue that the coil ¿looked skewed.¿ the information indicated that the ¿coil was repositioned once because it was not stable when first positioned, after repositioning it was still not stable and looked tilted or distorted, thus a new coil was used.¿ it was not known if when the coil was removed, there were additional damages observed.It was also reported as unknown if there were any blood flow restriction / reduction as a result of the reported issue.The information indicated that the procedure was completed with other cerenovus coils.It was unknown if there was any allegation of negative patient impact and it was unknown if the reported issue resulted in any clinically significant delay in the procedure.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 16-nov-2023.The returned product is pending evaluation.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 7mm x 30cm micrusframe 10 was received contained in the decontamination pouch.Visual inspection was performed.There were some kinks noted on the core wire; these kinks were found near the distal marker band where the core wire protrudes from the introducer.The coil was found inside the introducer.The embolic coil component was inspected under the microscope.Under magnification, it was observed to be in good condition (i.E., no kinks no stretched, or with non-concentric loops).The embolic coil is still attached to the resistance heating (rh) coil which was observed not softened; an indicating that the detachment process had not been initiated.The reported issue regarding the coil stuck inside the concomitant microcatheter could not be verified through functional testing due to the condition of the returned core wire preventing the ability to move the coil.According to the risk documentation, friction and difficulty to advance are potential issues that can occur during microcoil placement from the inability to position the microcoil, which can result in the core wire being kinked.The kinking of the core wire was not originally documented in the complaint; however, it could be the result of the difficulty experienced during the procedure that could not be replicated in the laboratory, and based on this the customer complaint was able to be confirmed.There is no indication that the issue reported is a result of a defect inherently related to the device.The reported issue that the coil looked skewed was not confirmed since the coil was found to be undamaged.The waviness on the proximal aspect of the embolic coil is a normal condition.A review of manufacturing documentation associated with this lot (30757481) 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.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) does contain the following recommendations: ¿ if unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rotating hemostasis valve (rhv) main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.¿ if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw, and examine the delivery catheter system.¿ do not fasten the rhv valve too tightly around the introducer sheath since excessive pressure may cause damage to the introducer sheath and/or the microcoil as it is advanced into the infusion microcatheter.Additionally, if the introducer tip and microcatheter hub are misaligned, damage may occur to the microcoil as it passes through this transition.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: MICRUSFRAME10 7MM X 30CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 17750111
• MDR Text Key: 323510947
• Report Number: 3008114965-2023-00639
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704077886
• UDI-Public: 10886704077886
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MFR100730
• Device Lot Number: 30757481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2022
• 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