MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3.5X9; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX3509
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization, an orbit galaxy xtrasoft coil (640cx3509, 30753136) was being used as the third coil.However, the physician felt strong resistance while advancing the coil.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.No additional information is available.Based on the analysis of the device received, the coil has a slightly damaged condition.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The coil has a slightly damaged condition, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Complaint conclusion: as reported by the field, during a coil embolization, an orbit galaxy xtrasoft coil (640cx3509, 30753136) was being used as the third coil.However, the physician felt strong resistance while advancing the coil.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.No additional information is available.A non-sterile the og cmplx xtrasoft coil 3.5x9 was received contained in the decontamination pouch.Upon receiving the device, a visual and microscopical inspection was performed.It was noted that the coil was partially inside the introducer; also, a knotted condition was found in the distal portion.No other damages were observed on the rest of the device.The coil was inspected under microscopic magnification, and it was found that at the point where the knot was found, the coil has a slightly damaged condition.The coil remains attached to the rest of the unit.A manufacturing record evaluation was performed for the finished device 30753136 number, and no non-conformances related to the malfunction were identified.The customer complaint regarding resistance could not be evaluated through functional testing due to the conditions in which the device was received, as the knot found prevented the coil from being retracted inside of the introducer.This condition was not originally reported in the complaint and is not considered a contributing factor to the reported failure.Also, it should be noted that with the limited information available, the exact time of when the embolic coil became knotted cannot be determined, and the failure cannot be replicated in the laboratory.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.Coil damage is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.Damage can occur during procedure handling where force may have been inadvertently applied.A manufacturing record evaluation was performed, and no non-conformance was found during the review.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.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.As part of the 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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.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.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) corrected data: d4 and h4.

• Brand Name: OG CMPLX XTRASOFT COIL 3.5X9
• 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): 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 ; 3035526892
• MDR Report Key: 16137225
• Report Number: 3008114965-2023-00028
• Device Sequence Number: 20495930
• Product Code: KRD
• UDI-Device Identifier: 10886704030690
• UDI-Public: 10886704030690
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 01/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 640CX3509
• Device Catalogue Number: 640CX3509
• Device Lot Number: 30753136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2022
• 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
• Patient Sex: Unknown