MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3X6; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 640CX0306

Device Problems Stretched (1601); Failure to Advance (2524)

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

Event Date 05/11/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4) information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section e.1: the name, phone and email address of the initial reporter are not available / reported.Section h.3: the product was received in the product analysis lab on 15-jun-2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.A review of manufacturing documentation associated with this lot (30620247) 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.

Event Description

The healthcare professional originally reported that a catheter was kinked at ¿5cm from the hub or tip.When it was first opened.¿ the physician used a ¿same like¿ product and the procedure was successfully completed.There was no report of any negative patient impact.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.On (b)(6) 2023, the product analysis lab received the returned package that contains an orbit galaxy coil and a trufill syringe.A request for clarification related to the products received and the original event description documented in the complaint was made.A response was received from the korean affiliates on 28-jun-2023 revising the original reported event to the following: ¿as a result of inquiring with logistics, it was confirmed that the syringe was included by mistake and was not related to the defective product.¿ a request was also made to update the reported event to the following: ¿this coil [3mm x 6cm orbit galaxy complex xtrasoft (640cx0306 / 30620247)] was the second coil.The coil could not be advanced nor retrieved by the physician.The physician pulled the coil and the [microcatheter] at the same time.After inspection, it turned out to be stretched.The physician used a same like product.The procedure was successfully finished.¿ there was no report of any negative patient impact.Based on the additional information received on 28-jun-2023, with the updated event description, the event has been deemed usfda reportable under 21 cfr 803 with a classification of ¿malfunction.¿.

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 3mm x 6cm orbit galaxy complex xtrasoft was received contained in the decontamination pouch.Visual inspection was performed.It was observed that the hypo-tube was broken in two (2) pieces; it was also observed to be kinked condition.The returned complaint device underwent microscopic inspection.It was observed that the embolic coil was no longer attached to the gripper and it was not returned.The gripper was inspected and no elongation marks were found; an indicated that the coil was mechanically detached.The issue documented in the complaint that the coil could not be advanced nor retrieved by the physician could not be evaluated through proper functional test since the device was returned incomplete.However, the condition of the hypo-tube suggests that the device was forcibly advanced due to the resistance encountered during the procedure and the issue can be confirmed based on this finding.According to the risk documentation, delivery tube / embolic coil not pushing through the microcatheter or encountering resistance in microcatheter is a potential failure mode that can occur during embolic coil placement due to 1) excessively tortuous anatomy, 2) incompatibility with microcatheter, 3) clot formation in the microcatheter.The coil stretching as reported in the event cannot be confirmed since the embolic coil component was not returned for further evaluation; the complaint detailed that there was no additional damage noted on the coil aside from the stretched condition.The coil detachment was not originally reported in the complaint, and its exact time of occurrence cannot be determined based on the amount of evidence available; thus, it is not considered a contributing factor nor a consequence of the reported failure.Coil stretching is a known potential issue associated with the use of this device.According to the risk documentation, coil stretching can occur during embolic coil placement due to excessive system manipulation, which may have been prompted by the resistance encountered during the procedure.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issues from occurring.It is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.A review of manufacturing documentation associated with this lot (30620247) 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 product failure could be caused by multiple factors.The instructions for use (ifu) contain the following precaution: ¿ 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.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: OG CMPLX XTRASOFT COIL 3X6
• 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): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 17228086
• MDR Text Key: 318347362
• Report Number: 3008114965-2023-00449
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704030591
• UDI-Public: 10886704030591
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K093973
• 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
• Report Date: 08/02/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 640CX0306
• Device Catalogue Number: 640CX0306
• Device Lot Number: 30620247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2021
• 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