MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 2.5X5; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX2505
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was found mechanically detached from the unit, 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.(b)(6) 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, there was a resheathing failure with a 2.5x5 og cmplx xtrasoft coil (640cx2505, 30003311).The introducer system was broken during recapture.There was no patient injury reported.Based on the device analysis of the 2.5x5 og cmplx xtrasoft, the coil was found mechanically detached from the unit.One non-sterile unit og cmplx xtrasoft coil 2.5x5 was received inside of a pouch.The received device was visually inspected, and the introducer was found in good condition and partially zipped.The gripper was found out of position and protruded from the introducer.Then a microscopic inspection was performed, the embolic coil was found mechanically detached from the unit.A manufacturing record evaluation was performed for the finished device 30003311 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil introducer - zipping difficulty-rezipping¿ was not confirmed, the device was able to zipped and re-zipped.The complaint reported by the customer ¿coil introducer- damaged¿ was not able to be confirmed.The introducer was found without damages.Since the gripper was found out of position and added to the fact that the embolic coil was found stuck by a dry clot we can assume that the coil was mechanically detached.When the gripper comes off the embolic coil remained inside the introducer tube.This cannot be determined with certainty since this condition was not reported in the initial event.The mechanically detached condition appears to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the mre suggests that the failure reported 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.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, during a coil embolization, there was a resheathing failure with a 2.5x5 og cmplx xtrasoft coil (640cx2505, 30003311).The introducer system was broken during recapture.There was no patient injury reported.Based on the device analysis of the 2.5x5 og cmplx xtrasoft, the coil was found mechanically detached from the unit.

• Brand Name: OG CMPLX XTRASOFT COIL 2.5X5
• 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: 10092147
• Report Number: 3008114965-2020-00199
• Device Sequence Number: 3122342
• Product Code: KRD
• UDI-Device Identifier: 10886704030652
• UDI-Public: 10886704030652
• Combination Product (Y/N): N
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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: 11/30/2017
• Device Model Number: 640CX2505
• Device Catalogue Number: 640CX2505
• Device Lot Number: 30003311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1