MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 2.5MMX6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CDF10025630
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
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 to being damaged, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2019-01285 and 3008114965-2019-01282.Complaint conclusion: as reported by an affiliate, during a coil embolization, a 2.5mmx6cm deltapaq cere coil (cdf10025630, c40100) failed to resheath.There was no patient injury reported.No additional information was provided at the time of reporting.Based on the device analysis, the embolic coil was found damaged.A non-sterile unit deltapaq cere 2.5mmx6cm was received inside of a pouch.The hub was inspected, and no damages was noted on it.The dpu was inspected and it was found kinked near to strain relief, 11 cm and 58 cm.Also the dpu was found protruded from introducer.The re-sheathing tool was inspected, and it was found broken in two.The introducer was inspected, and it was found without damages.The v-notch was inspected under microscope and it was found in good normal conditions.The rh and the articulation joint were inspected under microscope and they were found without damages.As well as the rh was not heated.The embolic coil was inspected under microscope and it was found with a damage condition.The functional test could not be performed due the conditions of the device.A manufacturing record evaluation was performed for the finished device c40100 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 evaluated due the conditions of the device.However, could not be determinate the exact time when (kinked and protruded condition from dpu and the broken condition from the re-sheating tool) were occurred, since apparently the device was used during the procedure.The kinked and protruded condition observed on the dpu is related with the costumer complaint and may have appeared to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.The broken condition observed on the re-sheating tool could related with the costumer complaint and may have appeared to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the analysis nor the mre suggest that the failure reported by the costumer 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.Coil stretched is a known potential complication associated with the use of a microcoil in the treatment of intracranial aneurysms.The root cause of the event cannot be conclusively determined based on the minimal information available for review.However, coil damage is an indicative of the application of excessive force, possibly in an attempt to overcome resistance.Excessive force applied to a coil through repeated coil deployments or manipulation can increase the possibility of coil damage.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 an affiliate, during a coil embolization, a 2.5mmx6cm deltapaq cere coil (cdf10025630, c40100) failed to resheath.There was no patient injury reported.No additional information was provided at the time of reporting.Based on the device analysis, the embolic coil was found damaged.

• Brand Name: DELTAPAQ CERE 2.5MMX6CM
• 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: 9475021
• Report Number: 3008114965-2019-01285
• Device Sequence Number: 16856937
• Product Code: HCG
• UDI-Device Identifier: 00878528007142
• UDI-Public: 00878528007142
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K080437
• 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): 10/10/2019

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: 12/31/2020
• Device Catalogue Number: CDF10025630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1