MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG HELICAL XTRSOFT COIL 2X4; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640HX0204
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
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.Procode: krd/hcg.Initial reporter phone: (b)(6).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.The photo received with the complaint did not provide any relevant information about the failure reported by the customer.The only photo provided had with some labels of the device and a part of the packaging.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
As reported by the field, during a coil embolization, a 2x4 orbit galaxy xtrasoft coil (640hx0204) failed to detach.It was reported that the coil couldn't be detached when it arrived at the target position.The physician withdrew the coil outside of the patients body and switched to another device to complete the surgery.There was no injury reported.A picture was received at the time of complaint entry.
Additional Manufacturer Narrative
Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a coil embolization, a 2x4 orbit galaxy xtrasoft coil (640hx0204, 30508721) failed to detach.It was reported that the coil couldn't be detached when it arrived at the target position.The physician withdrew the coil outside of the patient¿s body and switched to another device to complete the surgery.There was no injury reported.Additional information received indicated that the coil was still attached to the coil delivery system when removed from the patient.The coil was not stretched or damaged when removed from the patient.It was not necessary to remove the concomitant device with the complaint device.No excessive force was applied to the device.There was no significant prolongation in the procedure due to the event.The target vessel/site being treated was the left internal carotid artery.A non-sterile unit og helical xtrsoft coil 2x4 was received inside of a pouch.The device was visually inspected, and it was found in good normal conditions, no damages or anomalies were observed during the visual analysis.The embolic coil was inspected under a microscope, and it was found in good normal conditions, no damages or anomalies were observed on it.The og helical xtrsoft coil 2x4 was flushed using a lab sample syringe, then the device was purging on the blue zone; after that the pressure gauge was increased to the green zone and the coil was detached without any difficulty.A manufacturing record evaluation was performed for the finished device 30508721 number, and no non-conformances related to the malfunction were identified.A manufacturing record evaluation (mre) was performed for the finished device 30508721 number, and no non-conformances related to the malfunction were identified.Cerenovus conducted a visual inspection, microscopic examination and functional test.During the visual analysis of the device, it was noted that the og helical xtrsoft coil 2x4 is in good conditions.During the microscopic inspection was found that the embolic coil is in good normal conditions, no damages or anomalies were found on it.A functional test was performed, the og helical xtrsoft coil 2x4 was flushed using a lab sample syringe, then the device was purging on the blue zone; after that the pressure gauge was increased to the green zone and the coil was detached without any difficulty.The event described could not be confirmed as the functionality of the device was performed without any difficulties.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.Failure to detach is a known potential issue associated with the use of this device.It should be noted that product failure is multifactorial.The instructions for use (ifu) do contain the following directions: ¿ prepare the syringe with sterile saline solution as instructed in the syringe instructions for use.If the syringe was previously used to detach a coil, confirm the maximum number of coil detachments or attempts is not exceeded.¿ do not exceed position 3, green zone, as this could cause the syringe to lose calibration.If position 3, green zone, has been exceeded, do not reuse the syringe for additional coil detachments.Maintain the pressure in position 3, green zone for approximately 3 seconds.Rapidly decreasing pressure indicates that the coil has been detached; however, detachment must be confirmed under fluoroscopy.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.As part of cerenovus quality process all devices are manufactured, inspected, and released to approved specifications.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.
Additional Manufacturer Narrative
Product complaint (b)(4).Section a2: date of birth ¿ the year of birth was (b)(6) 1960, however, the month and date of birth was not reported.Section b5:additional information received indicated that the coil was still attached to the coil delivery system when removed from the patient.The coil was not stretched or damaged when removed from the patient.It was not necessary to remove the concomitant device with the compliant device.No excessive force was applied to the device.There was no significant prolongation in the procedure due to the event.The target vessel/site being treated was the left internal carotid artery.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: OG HELICAL XTRSOFT COIL 2X4
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 12276057
• Report Number: 3008114965-2021-00369
• Device Sequence Number: 14618627
• Product Code: KRD
• UDI-Device Identifier: 10886704030713
• UDI-Public: 10886704030713
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2021

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: 12/31/2022
• Device Model Number: 640HX0204
• Device Catalogue Number: 640HX0204
• Device Lot Number: 30508721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 08/23/2021; 09/14/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/13/2021; 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 41