MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 35 DETACHABLE; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-750617
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a transjugular intrahepatic portosystemic shunt (tips) procedure with variceal embolization, the coil prematurely detached when being repositioned and could no be retracted.A snare device was used to retrieve the coil into the base catheter.A new catheter and two more coils of the same model and size were selected and used successfully to complete the case.No adverse effect to the patient was noted.
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was reported available for return but has not yet been received.Therefore, at this time, the product analysis could not be performed and the alleged product issue cannot be verified.If the device or additional new information is received, a supplemental report will be submitted.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Additional Manufacturer Narrative
No additional event information was received.The device was received and has been evaluated.Additional information: d10 (date device returned), h6, h10 (device evaluation).Investigation findings: items returned for evaluation: implant, items not returned for evaluation: pusher, introducer, catheter.The implant was returned stretched at the proximal section and separated from the pusher.The pusher was not returned for evaluation.Therefore, this investigation could not determine the mode of separation.Investigation conclusion: the reported complaint is non-verifiable.The investigation of the returned coil system found the implant to be stretched and separated from the pusher.The pusher was not returned for evaluation.Without the return and evaluation of the pusher to inspect the attachment monofilament, the investigation is unable to determine the mode of separation (i.E., unintentional vs normal detachment using a detachment controller).Since the investigation could not verify the mode of implant separation due to the absence of the pusher, the reported event is considered non-verifiable.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched implant, but this condition is consistent with the device experiencing forces exceeding the implant's yield strength.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 20363720
• Report Number: 2032493-2024-00732
• Device Sequence Number: 3689032
• Product Code: KRD
• UDI-Device Identifier: 00812636021041
• UDI-Public: (01)00812636021041(11)220607(17)270531(10)0000204956
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 45-750617
• Device Lot Number: 0000204956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4FR GLIDECATH COBRA (TERUMO MEDICAL).; AZUR CX 35 DETACHABLE COILS (X2) (MICROVENTION).; SNARE DEVICE (UNKNOWN).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown