MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL AGILITY .010 195CM STANDARD; WIRE, GUIDE, CATHETER, NEUROVASCULAR

Model Number	614-178
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by a consumer that a patient underwent embolization of a spinal dural arteriovenous malformation (avm) using a 195 cm agility.010 guidewire (product code: 614178, lot unknown), which fractured during the procedure and was left inside the patient.The wire was tracked out in very tortuous anatomy and while the catheter was advanced the wire fractured.The surgery was delayed for more than 60 minutes.The guidewire was not able to be removed using a snare, but the procedure was completed successfully.Fragments were generated and they were not easily removed without additional intervention.Per the event description, the patient experienced unspecified consequences, but there was no clinical outcome experienced by the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The lot number was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: it was reported by a consumer that a patient underwent embolization of a spinal dural arteriovenous malformation (avm) using a 195 cm agility.010 guidewire (product code: 614178, lot unknown), which fractured during the procedure and was left inside the patient.The wire was tracked out in very tortuous anatomy and while the catheter was advanced the wire fractured.The surgery was delayed for more than 60 minutes.The guidewire was not able to be removed using a snare, but the procedure was completed successfully.Fragments were generated and they were not easily removed without additional intervention.Per the event description, the patient experienced unspecified consequences, but there was no clinical outcome experienced by the patient.A non-sterile agility guidewire was received contained in a decontamination pouch.Upon arrival, visual inspection was performed, and no kinks or any physical damage was noted on the agility guidewire.However, the distal tip of the guidewire was detached and not returned with the rest of the device.Hydrophilic coating was confirmed to be present on the remaining distal portion.The returned guidewire fragment was confirmed to measure 184 cm.As for the diameter, it was found to be out of specifications for the reported product (.010), this measurement indicated that the returned fragment belongs to an agility.014 instead.Due to the device was received incomplete, the working length could not be obtained to confirm which catalogue number this device belongs to.Attempts to obtain additional information have not been successful and clarification regarding the returned device has not been obtained.The manufacturing record evaluation (mre) cannot be performed due to the lot number was not provided.The customer complaint regarding guidewire being fractured was confirmed.The complaint documented that the wire was tracked out in very tortuous anatomy, which might have led to the fracture as reported.However, with the limited information available, assignment of root cause is not possible, and no further evaluation could be performed.Factors not described within the available information may have contributed to the issue encountered, should additional information is made available at later date, this investigation will be re-assessed.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contains the following recommendations/cautions: should the guidewire tip become entrapped within the vasculature (i.E., small side branch), do not torque the guidewire.Advance the microcatheter distally, gently pull the guidewire back into the microcatheter, and remove the microcatheter/guidewire system as a unit.A fractured and separated wire could embolize, resulting in ischemia or infarct.Since the event required additional intervention (i.E., snare) the event meets mdr reporting criteria with the classification of ¿serious injury¿.The file will be re-reviewed if additional information is received at a later date.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: AGILITY .010 195CM STANDARD
• Common Device Name: WIRE, GUIDE, CATHETER, NEUROVASCULAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14696327
• Report Number: 3008114965-2022-00437
• Device Sequence Number: 5176149
• Product Code: MOF
• UDI-Device Identifier: 10886704029038
• UDI-Public: 10886704029038
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K991646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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 Model Number: 614-178
• Device Catalogue Number: 614178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown