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

Model Number	45-750617
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: coil was passed through a 5fr catheter and pulled back into the catheter, then pushed out again to be pulled back a second time.With the second pull back, the coil became stuck and the md continued to pull until the pusher wire broke.The catheter was pulled out of the patient with the coil stuck in the end of the catheter.Upon visual inspection and under fluoroscopy, the md believes all of the coil was removed.The coil was passed all the way out the end of the catheter into to patient and then the attempt to pull the coil back out of the patient was made.There was no attempt to detach the coil with the detachment device.The coil and pusher wire was broken inside the catheter with the coil partially sticking out of the catheter all while inside the patient.Type of procedure performed: splenic aneurysm embolization.No patient injury reported.
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 has been returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Items returned for evaluation: pusher; implant; catheter.Items not returned for evaluation: introducer; shrink lock; dispenser hoop.The visual analysis of the returned device found that the pusher strain relief was damaged, the implant was not attached to the pusher, and the pusher was kinked at the distal section.The implant was returned stretched at the proximal section, separated from the pusher, and partially stuck within the distal end of the catheter.The returned catheter was not found to be damaged.The investigation found the pusher's monofilament broken, which indicates that the device experienced a tensile break.The investigation of the returned coil system found the pusher strain relief damaged, the pusher kinked at the distal section, and the implant stretched at the proximal section, separated from the pusher, and partially stuck within the distal end of the catheter; 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 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 returned catheter was not found to be damaged and would not have caused or contributed to the reported complaint.
Event or Problem Description
As reported: coil was passed through a 5fr catheter and pulled back into the catheter, then pushed out again to be pulled back a second time.With the second pull back, the coil became stuck and the md continued to pull until the pusher wire broke.The catheter was pulled out of the patient with the coil stuck in the end of the catheter.Upon visual inspection and under fluoroscopy, the md believes all of the coil was removed.The coil was passed all the way out the end of the catheter into to patient and then the attempt to pull the coil back out of the patient was made.There was no attempt to detach the coil with the detachment device.The coil and pusher wire was broken inside the catheter with the coil partially sticking out of the catheter all while inside the patient.Type of procedure performed: splenic aneurysm embolization.No patient injury reported.

• 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: 20306709
• Report Number: 2032493-2024-00713
• Device Sequence Number: 7624145
• Product Code: KRD
• UDI-Device Identifier: 00812636021041
• UDI-Public: (01)00812636021041(11)230809(17)280731(10)0000406035
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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: 0000406035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2023
• 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: GLIDECATH XP 5FR. COBRA 2.
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Hispanic
• Patient Race: White