MAUDE Adverse Event Report: . AZUR-35 DETACH PLATINUM; VASCULAR EMBOLIZATION DEVICE

Model Number	45-652050
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance 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 received and the investigation ongoing.Once the investigation is completed, a supplement report will be submitted.
Event or Problem Description
It was reported that during a splenic artery aneurysm embolization procedure, the coil had resistance when it was advanced to the tip of the catheter.When the physician repositioned the catheter away from the vessel wall, the coil would not advance.Then, the coil was attempted to be removed, but it detached.An attempt to inject the coil by flushing was performed and the pusher was used to advance the coil unsuccessfully.The catheter and coil were removed from the patient.No patient injury was report.
Additional Manufacturer Narrative
The investigation of the coil system found the implant returned stuck inside the catheter, stretched throughout, and 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 DETACH PLATINUM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): .; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14702283
• Report Number: 2032493-2022-00236
• Device Sequence Number: 5074542
• Product Code: KRD
• UDI-Device Identifier: 00810170016158
• UDI-Public: (01)00810170016158(11)200724(17)250630(10)2007245K8
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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 Expiration Date: 06/30/2025
• Device Model Number: 45-652050
• Device Catalogue Number: 45-652050
• Device Lot Number: 2007245K8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2020
• 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
• Patient Age: 52 YR
• Patient Sex: Female