MAUDE Adverse Event Report: MICROVENTION, INC. AZUR DETACHABLE 35 SYSTEMS; EMBOLIZATION COIL

Model Number	45-451015
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2018
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 device was returned for evaluation.The coil was noted to have overlapping throught the length, and the shape was deformed and stretched.A swelling of the gel was also noted throught the coil.Based on the available information and evaluation of the returned device, the complaint can be confirmed, the root cause cannot be determined; however, the device exhibits evidence that it was subjected to tensile forces that exceeded its strength specifications.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during placement of an embolization coil in the proximal portion of the left varicocele vessel, the physician attempted to advance the coil.The coil was half way out of the catheter, and the physician pulled back on the coil, and the coil detached in the catheter.An attempt was made to push the coil into the intended area; however, the coil hung down into the renal vein.The coil was successfully retrieved with a snare device.There was no reported patient injury.The patient is reported to be stable.

• Brand Name: AZUR DETACHABLE 35 SYSTEMS
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7724534
• Report Number: 2032493-2018-00148
• Device Sequence Number: 19175018
• Product Code: KRD
• UDI-Device Identifier: 00810170014963
• UDI-Public: (01)00810170014963(11)160223(17)210223(10)160223JC2
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K093002
• 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
• Report Date (Section B): 06/28/2018

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: Other
• Device Expiration Date: 02/23/2021
• Device Model Number: 45-451015
• Device Catalogue Number: 45-451015
• Device Lot Number: 160223JC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/26/2018
• 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: 18 YR
• Patient Weight: 65