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

Model Number	45-750609
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device has been returned to the manufacturer for evaluation.The investigation is currently ongoing.The device was used during the same procedure as was reported in mfr report# 2032493-2017-00108.
Event or Problem Description
It was reported that during treatment of a left groin a-v fistula, the coil "stuck to a jb4 catheter" and uncoiled.The coil was removed from the patient with a snare device.There was no reported patient injury.The current patient's status is reported to be "fine.".
Additional Manufacturer Narrative
The implant was returned without the pusher or catheter for evaluation.Analysis revealed a 3cm long stretched portion located 1cm from the proximal end, with sections distal to that with open gaps.The proximal end with the monofilament knot-tie and adhesive were noted to be intact.The monofilament had evidence of being thermally detached.There was no evidence of tensile failure of the monofilament.Based on the investigation and provided information, the complaint of a detached implant cannot be confirmed.The implant coil was note broken, but noted to be stretched; however, the analysis was unable to determine if the damage was caused by snaring the device as reported.The specific root cause cannot be determined.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6525768
• Report Number: 2032493-2017-00109
• Device Sequence Number: 1627807
• Product Code: KRD
• UDI-Device Identifier: 00812636021034
• UDI-Public: (01)00812636021034(11)160426(17)210426(10)16042611
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K122316
• 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,Followup
• Report Date (Section B): 03/31/2017

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: 04/26/2021
• Device Model Number: 45-750609
• Device Lot Number: 16042611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: 03/31/2017
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 10/30/2017
• 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: 75 YR
• Patient Weight: 128