MAUDE Adverse Event Report: MICROVENTION INC. AZUR CX 35 DETACHABLE; AZUR CX DETACHABLE

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	12/02/2024
Type of Reportable Event	Serious Injury
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 stated to be available for return to the manufacturer for evaluation but has not yet been returned.The alleged product issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that during the embolization procedure of a right renal artery, the coil prematurely detached from the pusher wire.While using a 6fr lima-shaped destination sheath with a 4fr glidecatheter, they had previously deployed four coils through this system.There were no issues advancing the coil through the glidecatheter.However, they lost catheter/sheath support towards the middle of the coil advancement and decided to recapture the coil.The physician started to pull back the pusher wire and the coil detached within the catheter/sheath.They were able to pull the glidecatheter out of the sheath and insert a snare to capture the coil.The coil was successfully removed with no patient harm.The procedure was finished with no further issues.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned coil system found the implant coil stretched at the proximal section and separated from the pusher.The pusher was not returned for evaluation.The investigation found that the implant's monofilament at the tie knot showed a tensile break shape at the tip, which is consistent with the device experiencing force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched implant, but stretching is consistent with the device experiencing forces exceeding the implant's yield strength.
Event or Problem Description
Please see h6 and h11.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: AZUR CX DETACHABLE
• 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: 20959214
• Report Number: 2032493-2024-00918
• Device Sequence Number: 7674613
• Product Code: KRD
• UDI-Device Identifier: 00812636021041
• UDI-Public: (01)00812636021041(11)241017(17)290930(10)0000734658
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 02/10/2025

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: 0000734658
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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 Age: 88 YR
• Patient Sex: Male
• Patient Weight: 36 KG