MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSPHERE XL 4MMX10CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	SSR100410-20
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2019
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 stretched, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.The product¿s lot number was not reported initial reporter: the customer contact information, including 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 a healthcare professional, during a coil embolization, when using a 4mmx10cm micrusphere xl (ssr10041020, lot unknown) as a last coil, the doctor placed the distal portion of the coil into the microcatheter hub, intact with white sheath and then try to advance the coil by stripping the plastic end of the coil from the proximal end.Then the dark green slider in the proximal end of the coil was moved to the left side towards distal portion of the coil and while the white string of plastic was peeled at the opposite end.During this process, peeling off the white strip was not done properly due to the fact that the coil couldn't advance through the microcatheter.After several attempts to rectify the process, the coil was not apt for the further procedure, this led to plastic being entangled in the dark green slider.Another coil was used to finish the procedure.There was no patient injury reported.The coil was initially removed from the dispenser hoop and there were no internal issues from the coil.One non-sterile unit micrusphere xl 4mmx10cm was received inside of a pouch.The received device was visually inspected, and the introducer was found damaged, the re-sheathing tool was found broken in two.Then a microscopic inspection was performed, the embolic coil was found stretched, no other damages were observed.The manufacturing record evaluation (mre) cannot be performed due to the lot number was not provided.The complaint reported by the customer ¿coil introducer - zipping difficulty-rezipping¿ could not be evaluated because the introducer was found damaged and the embolic coil was found stretched.However, the damaged condition noted on the introducer may have contributed to the failure and due to this we can confirm the complaint.The damaged condition noted on the introducer and the re-sheathing tool appears to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.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 a healthcare professional, during a coil embolization, when using a 4mmx10cm micrusphere xl (ssr10041020, lot unknown) as a last coil, the doctor placed the distal portion of the coil into the microcatheter hub, intact with white sheath and then try to advance the coil by stripping the plastic end of the coil from the proximal end.Then the dark green slider in the proximal end of the coil was moved to the left side towards distal portion of the coil and while the white string of plastic was peeled at the opposite end.During this process, peeling off the white strip was not done properly due to the fact that the coil couldn't advance through the microcatheter.After several attempts to rectify the process, the coil was not apt for the further procedure, this lead to plastic being entangled in the dark green slider.Another coil was used to finish the procedure.There was no patient injury reported.The coil was initially removed from the dispenser hoop and there were no internal issues from the coil.

• Brand Name: MICRUSPHERE XL 4MMX10CM
• 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: 9686521
• Report Number: 3008114965-2020-00023
• Device Sequence Number: 19678415
• Product Code: KRD
• UDI-Device Identifier: 00878528009948
• UDI-Public: 00878528009948
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K032872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2019

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 Model Number: SSR100410-20
• Device Catalogue Number: SSR10041020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1