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	02/10/2020
Type of Reportable Event	Malfunction
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 noted as being stretched, 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.Complaint conclusion: as reported by the field, a 3.5x5 og cmplx xtrasoft coil (640cx3505, 30396176) was being used as a second coil.The physician decided to pull it out for re-deployment after trying another size of coil first.When the physician tried to resheath the orbit galaxy coil, the introducer failed to be re-zipped.The physician used a same like product.The procedure was successfully finished.No additional information was provided.A non-sterile unit og cmplx xtrasoft coil 3.5x5 was received inside of a pouch.The device was inspected, and it was found that the hypo-tube is protruded from the introducer, no other damages or anomalies were observed during the visual analysis.The embolic coil was inspected under a microscope and it was found with a stretch condition.The functional test could not be performed since during the analysis it was noted that the hypo-tube is protruded from the introducer in good normal conditions, also, the embolic coil was found with a stretch condition.A manufacturing record evaluation (mre) was performed for the finished device 30396176 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil introducer - zipping difficulty-rezipping¿ could not be duplicated.During the inspection, it was noted that the hypo-tube is protruded from the introducer in good normal conditions, also the embolic coil was found with a stretch condition.These conditions are related with the customer¿s complaint regarding a zipping difficulty-rezipping and might appear to have been caused by excessive force and/or handling applied to the device, however, it cannot be determined the exact when this condition appeared.Based on the information obtained during the analysis, the customer complaint can be confirmed.Neither the analysis nor the mre suggests that the failure reported by the customer could be related to the manufacturing process.The instructions for use (ifu) instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil and the more flexible and fragile distal sections of the dpu inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing into the microcatheter, there is a risk that the embolic coil or the distal end of the dpu will be unsheathed and pass through the resheathing tool.If the resheathing tool passes over the distal end of the dpu, this will expose these flexible sections, which will then be subject to kinking and bending.Once a part of the dpu is kinked or bent, the translucent introducer sheath will not be able to re-form around it, and that section of the device will protrude.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.An embolic coil becomes stretched when an excessive pull force is applied to the device.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 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.
Event or Problem Description
As reported by the field, a 3.5x5 og cmplx xtrasoft coil (640cx3505, 30396176) was being used as a second coil.The physician decided to pull it out for re-deployment after trying another size of coil first.When the physician tried to resheath the orbit galaxy coil, the introducer failed to be re-zipped.The physician used a same like product.The procedure was successfully finished.Based on the product investigation on the device received, the embolic coil found with a stretch condition.

• 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
• MDR Report Key: 11342972
• Report Number: 3008114965-2021-00089
• Device Sequence Number: 13635408
• 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,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 640CX3505
• Device Catalogue Number: 640CX3505
• Device Lot Number: 30396176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1