MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3.5X5; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CX3505
Medical Device Problem Codes	Failure to Advance (2524); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
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.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.This is one of three products involved with the complaint and the associated manufacturer report numbers are 3008114965-2023-00828 and 3008114965-2023-00829.
Event or Problem Description
As reported by the field, during a coil embolization, an orbit galaxy xtrasoft coil (640cx0406, 30692754) and an orbit galaxy xtrasoft coil (640cx3505, 30706309) became stuck into a prowler select lpes microcatheter (606s155x, 31041133).It was also noted that there is a thread inside the packing of the coil.The procedure was delayed by 30 minutes.The devices were removed easily without additional intervention.A new coil and microcatheter (mc) were used to compete the procedure successfully.There was no report of patient injury.
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, an orbit galaxy xtrasoft coil (640cx0406, 30692754) and an orbit galaxy xtrasoft coil (640cx3505, 30706309) became stuck into a prowler select lpes microcatheter (606s155x, 31041133).It was also noted that there is a thread inside the packing of the coil.The procedure was delayed by 30 minutes.The devices were removed easily without additional intervention.A new coil and microcatheter (mc) were used to compete the procedure successfully.There was no report of patient injury.One non-sterile 3.5mm x 5cm orbit galaxy complex xtrasoft coil was received contained in the decontamination pouch.Upon receipt of the device, visual inspection was performed, and the hypo-tube was found with multiple kinked conditions.Under magnification, it was observed that the coil was no longer attached to the gripper, and this was not returned for evaluation.An elongation mark was noted in the distal portion of the gripper which suggests that the coil was mechanically detached from the unit.The issue documented in the complaint that the coil became stuck into the microcatheter could not be evaluated through functional testing since the device was returned with multiple kinked conditions which suggests that the device was forcibly advanced through the microcatheter in an attempt to overcome the resistance encountered and based on this the complaint was able to be confirmed.According to the risk documentation, the delivery system not maintaining integrity upon delivery during embolic coil introduction is a potential failure mode that can result in the coil not being delivered to the treatment site due to mishandling of the device during introduction.Continuous flush being interrupted during embolic coil introduction is another potential failure mode that can result in the coil not being delivered to the treatment site due to inappropriate drops from pressure bag, without an adequate flush, issues such as resistance between the coil and the microcatheter can arise.The issue regarding that there is a thread inside the packing of the coil was reported to have occurred before use; however, the device has been removed from its packaging and handled in an unknown manner and environment.Also, the original packaging was not returned for evaluation.Without the original package and the limited information available, the customer complaint cannot be evaluated and an assignment of a root cause cannot be determined.The mechanically detached condition of the embolic coil was not originally reported in the complaint.With the limited information available, the most likely time of occurrence is during embolic coil retrieval and thus is not considered related to the reported issue.A manufacturing record evaluation was performed for the finished device 30706309 number, and no non-conformances related to the malfunction were identified.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is proposed at this time.It should be noted that product failure is multifactorial.The instructions for use contain the following precautions and warnings: 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.During coil retraction, verify under fluoroscopy that a one-to-one relationship exists between the delivery tube and the coil.If not, the coil has been stretched, which could lead to premature detachment or coil fracture.If the one-to-one relationship does not exist, remove the infusion catheter and the detachable coil as an assembly and replace.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: OG CMPLX XTRASOFT COIL 3.5X5
• Common Device Name: 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. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18121567
• Report Number: 3008114965-2023-00827
• Device Sequence Number: 18044641
• Product Code: KRD
• UDI-Device Identifier: 10886704030683
• UDI-Public: 10886704030683
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2024

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: 11/30/2023
• Device Catalogue Number: 640CX3505
• Device Lot Number: 30706309
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: 12/18/2023; 12/28/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 12/18/2023; 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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: OG CMPLX XTRASOFT COIL 4X6; PROWLER SELECT LPES
• Patient Sex: Unknown