MAUDE Adverse Event Report: MICROVENTION, INC AZUR 35 CX DETACHABLE 10MM X 19CM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-751019
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
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 received.The coil detachment cannot be confirmed at this time.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 a snare was used to remove a coil after the coil pre-maturely detached inside a catheter.This coil detached when pulling the coil back to reposition the coil during an embolization just distal of the confluence of the ovarian, renal and lumbar veins to prevent reflux.The coil was advanced through the catheter and was approximately 3/4 of the way out of the catheter into the vein when the physician attempted to reposition the coil by pulling it back into the catheter.As it was pulled back, the coil detached pre-maturely inside the catheter.The physician tried to slowly advance the catheter to reposition the coil.The coil came out of the catheter and a portion of the coil was visible in the renal vein.The physician was able to snare the coil and successfully remove the coil from the patient.There was no reported patient impact or harm.
Additional Manufacturer Narrative
The investigation of the returned coil system found the proximal connector kinked, the strain relief damaged, and the implant separated from the pusher.No indication using a detachment controller was found on the pusher's 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.

• Brand Name: AZUR 35 CX DETACHABLE 10MM X 19CM
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15601484
• Report Number: 2032493-2022-00403
• Device Sequence Number: 2136911
• Product Code: KRD
• UDI-Device Identifier: 00812636021072
• UDI-Public: (01)00812636021072(11)220310(17)270228(10)0000167920
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K093002
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 45-751019
• Device Catalogue Number: 45-751019
• Device Lot Number: 0000167920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MERIT PERFOMA, 5FR, MP A2, 100 CM
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female