MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 4X8; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX0408
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	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization, a 4x8 orbit galaxy xtrasoft (640cx0408, 30620249) 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 the resheathing of the coil, the introducer failed to be re-zipped.The physician decided to pull it out because the coil's size was not appropriate with the aneurysm.The physician used a same like product.The procedure was successfully finished.Based on the product analysis of the device received, the embolic coil was found damaged.
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 found damaged, meeting regulatory reporting criteria.Procode: krd/hcg.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.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 4x8 orbit galaxy xtrasoft (640cx0408, 30620249) 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 the resheathing of the coil, the introducer failed to be re-zipped.The physician decided to pull it out because the coil's size was not appropriate with the aneurysm.The physician used a same like product.The procedure was successfully finished.A non-sterile og cmplx xtra soft coil 4x8 was received inside of a pouch.The hypotube of the orbit galaxy device was found in good conditions (e.G no kinks), the introducer showed evidence of use since it was peeled and the zipper was not reaching the most proximal end, which indicates that the introducer had been un-zipped.No other damages were noted.Under microscopic magnification, the introducer was noted to be slightly kinked and open.The embolic coil was observed to be damaged and non-concentric loops were also observed.The re-zipping functionality was verified, and the zipper could not be advanced past the kink present on the introducer.A manufacturing record evaluation (mre) was performed for the finished device 30620249 number, and no non-conformances related to the malfunction were identified.The device was returned to cerenovus for further evaluation.Upon arrival, the hypotube of the orbit galaxy device was found in good conditions (e.G no kinks), the introducer showed evidence of use since it 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 slightly kinked and open.This damage precluded the introducer to be completely re-zipped during the functional test and could be related to the issue reported.Further inspection under microscopic magnification revealed that the embolic coil was observed to be damaged and a focal separation of the adjacent loops was also observed.This damage is not considered a contributing factor to the re-zipping difficulty encountered during the procedure.The exact timing of when this condition occurred could not be determined.Coil damage 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 damage on the introducer prevented it from being re-zipped during the functional test and could be related to the issue reported.The customer complaint was confirmed based on this finding.Coil damage can occur during procedure handling where force may have been inadvertently applied.It is possible that force may have inadvertently been applied during the coil re-sheathing which resulted in the coil damage.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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 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 4X8
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14240632
• Report Number: 3008114965-2022-00308
• Device Sequence Number: 4338486
• Product Code: KRD
• UDI-Device Identifier: 10886704030638
• UDI-Public: 10886704030638
• 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): 04/28/2022

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: 06/30/2023
• Device Model Number: 640CX0408
• Device Catalogue Number: 640CX0408
• Device Lot Number: 30620249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• 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