MAUDE Adverse Event Report: MICROVENTION, INC AZUR 35 HYDROCOIL DETACHABLE; VASCULAR EMBOLIZATION DEVICE

Model Number	45-450820
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10 : 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 stated to be available for return to the manufacturer for evaluation but has not yet been returned.However, images were provided.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
As reported: the representative pulled a hydrocoil out of the box prior to a case.The hydrocoil package had a red rejected sticker on the back of the coil plastic packing.There was no other sticker or label noted on the box or exterior packaging of the coil.No other packages were found with a similar sticker.The sterile plastic packing was intact.The coil was never presented to a customer or used with a patient, no patient involvement.Although requested, no other information was made available.
Additional Manufacturer Narrative
Investigation findings: items received: 2 provided images of the reported azur-35 detachable hydro coil system packaging; azur-35 detachable hydro coil system.Items not received: n/a.Two images of the product pouch were provided for review.It can be observed that a red "rejected" sticker was present on the back of the product pouch.No abnormalities were observed on the front of the product pouch.The product pouch seals appeared intact.The device was returned and the red "rejected" sticker was present on the back of the product pouch as seen in the customer provided images.No "reject" stickers were observed on the outer product packaging, which is consistent with the information provided in the event description.Investigation conclusion: the investigation of the returned device found a red "rejected" sticker to be present on the back of the product pouch, which is consistent with the alleged product issue and the condition observed on the provided images.No ¿rejected¿ stickers/labels were observed on the outer product packaging.No abnormalities were observed on the front of the product pouch and the product pouch seals were intact.
Event or Problem Description
No additional information was received.

• Brand Name: AZUR 35 HYDROCOIL DETACHABLE
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19015160
• Report Number: 2032493-2024-00261
• Device Sequence Number: 8172829
• Product Code: KRD
• UDI-Device Identifier: 00810170014956
• UDI-Public: (01)00810170014956(11)230816(17)280731(10)0000409462
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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: Other
• Device Model Number: 45-450820
• Device Lot Number: 0000409462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown