MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 10 ADVANCED; EMBOLIZATION COIL

Model Number	7110-0410
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A lot history trend review was performed and there were no similar complaints for this lot number.The device has not been returned to the manufacturer.A photograph of the packaging was provided.The investigation is currently underway.
Event or Problem Description
It was reported that after the coil had been removed from the sterile pouch and the scrub tech was getting ready to prep the coil, the company representative noticed that the coil hoop did not look "right" and checked the device package labels, which indicated an azur cx 18 peripheral coil was inside the hydroframe 10 neuro coil box.The coil was not used in the patient.
Additional Manufacturer Narrative
The device was returned with the introducer, pusher, and the implant coil for analysis.The returned device was the hydroframe 10 and the device was noted to be within specifications; however, the label used to print the information for this device was incorrect.The label was for a azur cx d18 coil.The investigation did not confirm that the returned part or device inside the package was incorrect.The label used on the packaging was incorrect.Instead of using the hydroframe 10 label information, the label used was for an azur cx d18.The information related to the device, the size, and the lot number were correct.An investigation was opened to address package labelling issues.

• Brand Name: HYDROFRAME 10 ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8196849
• Report Number: 2032493-2018-00285
• Device Sequence Number: 11193065
• Product Code: HCG
• UDI-Device Identifier: 00816777025234
• UDI-Public: (01)00816777025234(11)180314(17)230228(10)1803145YB
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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 Expiration Date: 02/28/2023
• Device Model Number: 7110-0410
• Device Lot Number: 1803145YB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1