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

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	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the case was a right internal iliac aneurysm embolization.Access for the embolization used a 7f 45cm destination sheath placed directly into the right iia & a 4f 65cm angled glidecath was used for coil delivery.After 7 azur coils were successfully delivered the next coil was the 6mmx17cm.After each coil detachment the catheter was flushed with saline.During the placement of the 6mmx17cm coil while advancing the coil into the coil pack the coil detached from the pusher wire half inside the coil pack & inside the catheter.The physician tried to push the coil into the pack with another wire but the coil would not track out of the catheter.The physician decided to take out the 4f glidecath with the coil inside the catheter.The coil come out intact.He flushed the 4f catheter & placed it back into the coil pack to continue the case.The next coil that went through the catheter deployed successfully.A second vessel was embolized but we used a 65cm navi for the deployment of the last 5 coils.Embolization of iia aneurysm was a success with vessel occlusion.No patient injury was reported.
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.The device has been returned for evaluation.A supplemental mdr will be submitted following the completion of the investigation.
Additional Manufacturer Narrative
Items returned for evaluation: pusher, implant, catheter.Items not returned for evaluation: introducer, dispenser hoop, shrink lock, v-grip.The visual analysis of the returned items found that the implant was not attached to the pusher.The implant was returned stretched at the proximal section and separated from the pusher.Investigation of the pusher found the monofilament broken, indicating that the device experienced a tensile break.The returned catheter was found to be flattened at 11cm and 39cm from the proximal tip of the hub.The investigation of the returned coil system found the implant stretched at the proximal section and separated from the pusher.The investigation found the pusher's monofilament with 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 retraction forces over specification.The catheter used with the coil system during the procedure was found to be flattened at 11cm and 39cm from the proximal tip of the hub, which may have caused or contributed to the reported complaint.
Event or Problem Description
See h10.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: PERIPHERAL
• 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: 19149639
• Report Number: 2032493-2024-00314
• Device Sequence Number: 7800618
• Product Code: KRD
• UDI-Device Identifier: 00812636021041
• UDI-Public: (01)00812636021041(11)230810(17)280731(10)0000406843
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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: 45-750617
• Device Lot Number: 0000406843
• Was Device Available for Evaluation?: Yes
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/07/2024
• 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: Other
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 69 KG