MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX DETACHABLE; EMBOLIZATION COIL

Model Number	45-750824
Medical Device Problem Codes	Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.The implant coil was returned for evaluation, and it was not attached to the delivery pusher.The delivery pusher was not returned for analysis.Images taken under magnification confirm the proximal end of the implant coil is stretched.It is unknown at what point during the procedure the coil became stretched.The method of the detachment cannot be determined; however, the coil exhibits evidence of being subjective to a force that exceeded its maximum tensile specification.The investigation is inconclusive and the root cause is unknown.
Event or Problem Description
It was reported that coil embolization of the gonadal vein for a varicocele was attempted.During the procedure, the catheter "came back" and the azur cx coil unexpectedly detached, buckled, and went into the renal vein.The detached coil was removed with a wire.The patient tolerated the procedure well and there were no immediate complications.There was no reported patient injury.The procedure outcome was successful.

• Brand Name: AZUR CX DETACHABLE
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6252927
• Report Number: 2032493-2017-00021
• Device Sequence Number: 769657
• Product Code: KRD
• UDI-Device Identifier: 00810170018039
• UDI-Public: (01)00810170018039(11)161005(17)210930(10)161005LC1
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K071939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/25/2021
• Device Model Number: 45-750824
• Device Lot Number: 16042511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2016
• Initial Report FDA Received Date: 01/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 19 YR