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

Model Number	45-752039
Medical Device Problem Codes	Difficult to Advance (2920); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a barto procedure, the embolization coil encountered resistance within the catheter.During attempt to remove the coil, the coil prematurely detached from the delivery pusher.The catheter was viewed under fluoro confirming the coil remained in the catheter.The coil and catheter were successfully removed from the patient.No patient harm or 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 device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature coil detachment as potential complications associated with use of the device.
Additional Manufacturer Narrative
Items returned for evaluation: implant; microcatheter.Items not returned for evaluation: pusher; introducer; dispenser hoop; shrink lock; v-grip.The visual analysis of the returned items found the implant returned partially advanced through the microcatheter with the coils stretched at the proximal section.The pusher was not returned for investigation.The implant was retrieved from the microcatheter and found the monofilament broken, indicating that the device experienced a tensile break.

• 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: 16811935
• Report Number: 2032493-2023-00687
• Device Sequence Number: 5683329
• Product Code: KRD
• UDI-Device Identifier: 00812636021102
• UDI-Public: (01)00812636021102(11)230131(17)271231(10)0000317297
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• 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): 04/09/2023

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: 45-752039
• Device Catalogue Number: 45-752039
• Device Lot Number: 0000317297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2023
• 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: 04/09/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2023
• 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: 65CM C2 GLIDECATH
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male