MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 HYDROCOIL PUSHABLE 4MM X 6CM; VASCULAR EMBOLIZATION DEVICE

Model Number	45-280406
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: initial reporter phone number: (b)(6).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 not returned to the manufacturer for analysis.The alleged product issue could not be confirmed.
Event or Problem Description
It was reported that an embolization coil implant was missing from the tip of the delivery pusher when the device was removed from its packaging.There was no patient involvement.

• Brand Name: AZUR 18 HYDROCOIL PUSHABLE 4MM X 6CM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 11904936
• Report Number: 2032493-2021-00198
• Device Sequence Number: 3648690
• Product Code: KRD
• UDI-Device Identifier: 00810170012181
• UDI-Public: (01)00810170012181(11)200824(17)230731(10)200824548
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: K071939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2021

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: 07/31/2023
• Device Model Number: 45-280406
• Device Catalogue Number: 45-280406
• Device Lot Number: 200824548
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR