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

Model Number	45-750812
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a pelvic embolization 035 catheter was in place, coil was advanced outside of catheter during the end of coil placement.The physician was manipulating the posterior end of the coil pulling in and out of the catheter multiple times at one point the coil wouldn't move in correlation to the pusher wire.The coil was then attempted to detach.When the pusher coil was retracted to coil was stuck within the catheter.The catheter was then pulled back into the sheath and back out of the patient.Additional information indicated, the coil became dislodged from the pusher wire.Detachment attempt failed.The entire system was then retracted back in to the catheter and pulled out.No patient injury occurred.
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 to the manufacturer.A supplemental mdr will be submitted following the completion of the investigation.
Additional Manufacturer Narrative
Items returned for evaluation: pusher.Implant.Items not returned for evaluation: introducer.Shrink lock.Dispenser hoop.Microcatheter.V-grip.The visual analysis of the returned items found the pusher's strain relief damaged and the implant not attached to the pusher, but no signs of activation was observed on the pusher heater coil.The implant was returned stretched at the proximal section with the gel exposed, damaged, deformed and separated from the pusher.The investigation found the pusher's monofilament broken (img c), which indicates the device experienced a tensile break.The investigation of the returned coil system found the strain relief damaged, and the implant stretched at the proximal section with the gel exposed, damaged, deformed and separated from the pusher; however, no indications of activation using a detachment controller was found on the pusher heater coil.The investigation found the pusher's monofilament with a tensile break shape at the tip, which is consistent with the device experiencing excessive 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 damage, but the damage is consistent with the device experiencing forces over specification.The microcatheter used in the procedure was not returned for evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.

• 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: 19102212
• Report Number: 2032493-2024-00297
• Device Sequence Number: 15379780
• Product Code: KRD
• UDI-Device Identifier: 00812636021058
• UDI-Public: (01)00812636021058(11)230417(17)280331(10)0000350363
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

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: 45-750812
• Device Lot Number: 0000350363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 113 KG