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

Model Number	640CX3505
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization, a 3.5x5 orbit galaxy xtrasoft (640cx3505, 30526765) was being used as a first coil.The physician decided to pull it out for re-deployment after trying another size of coil first.During resheathing the coil, the introducer failed to be re-zipped.The physician decided to pull it out because coil's size is not appropriate with aneurysm.The physician used a same like product.The procedure was successfully finished.Based on the device analysis of the device received the embolic coil was kinked.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was kinked, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.Complaint conclusion: as reported by the field, during a coil embolization, a 3.5x5 orbit galaxy xtrasoft (640cx3505, 30526765) was being used as a first coil.The physician decided to pull it out for re-deployment after trying another size of coil first.During resheathing the coil, the introducer failed to be re-zipped.The physician decided to pull it out because coil's size is not appropriate with aneurysm.The physician used a same like product, the procedure was successfully finished.A non-sterile og cmplx xtra soft coil 3.5x5 was received inside of a pouch.The hypotube was observed all entangled.The introducer was noted to show evidence of use since was peeled and the zipper was not reaching the most proximal end, which indicates that the introducer had been un-zipped.The introducer was noted to be kinked and open.The embolic coil was noted to be kinked.The functional test could not be performed due to the unit condition received.A manufacturing record evaluation (mre) was performed for the finished device [30526765] number, and no non-conformances related to the reported complaint condition were identified.Upon arrival of the device for analysis, the hypotube was observed all entangled.The introducer was noted to show evidence of use since was peeled and the zipper was not reaching the most proximal end, which indicates that the introducer had been un-zipped.Under microscopic magnification, the introducer was noted to be kinked and open.This damage could be related to the issue reported.Further microscopic inspection revealed that the embolic coil was kinked.This damage is not considered a contributing factor to the re-zipping issue encountered during the procedure, however, the exact timing of when this condition occurred could not be determined.Coil kinking is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.The introducer damages described above prevented the introducer to be re-zipped during the functional test and could be related to the issue reported.The customer complaint was confirmed based on the findings observed.A manufacturing record evaluation was performed, and no non-conformance was found during the review.It should be noted that product failure is multifactorial.The instructions for use (ifu) do contain the following precaution: never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.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 failures and damages on the returned 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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• 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): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13840086
• Report Number: 3008114965-2022-00203
• Device Sequence Number: 20016291
• Product Code: KRD
• UDI-Device Identifier: 10886704030683
• UDI-Public: 10886704030683
• Combination Product (Y/N): N
• 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
• Type of Report: Initial
• Report Date (Section B): 03/21/2022

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: 01/31/2023
• Device Model Number: 640CX3505
• Device Catalogue Number: 640CX3505
• Device Lot Number: 30526765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2021
• 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
• Patient Sex: Unknown