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

Model Number 7110-0415-A2

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Stretched (1601)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

The lot number was provided, and the device history records are being reviewed.The device has been returned to the manufacturer.The investigation is currently underway.

Event Description

It was reported that during positioning of the last embolization coil in a basilar artery aneurysm, the microcatheter kept backing out as the coil was being advanced.During an attempt to remove the coil and the microcatheter, the coil appeared to break or stretch.The coil was then intentionally detached with the controller; however, the coil detached at one of the pusher wire zones, which resulted in two detached segments left behind in the patient.The detached coil and pusher zone were successfully retrieved with a snare device.There was no reported patient injury.The patient is reported to be stable and in good condition.

Manufacturer Narrative

The device was received for evaluation inside a catheter with partial pusher exposed.The implant coil was detached and stretched at the proximal end.The distal black pet was burnt, indicating several detachment attempts.The monofilament exposed on the marker band proximal end shows thermal cycling, as well as tensile pull.The pusher resistance was noted to be within specification.Based on the investigation and provided information, the complaint cannot be confirmed.The root cause cannot be determined.The implant stretch was most likely caused due to snagging at the stent wall when the catheter snapped back from the aneurysm sac.The implant coil may have been resheathed and exposed in between the stent and the vessel wall.The detachment attempt may have been made when the implant coil was still in the vessel, outside the catheter.

• Brand Name: HYDROFRAME 10 ADVANCED
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: debby callahan ; 1311 valencia avenue; tustin, CA 92780 ; 7142478000
• MDR Report Key: 6378969
• MDR Text Key: 69095576
• Report Number: 2032493-2017-00054
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Model Number: 7110-0415-A2
• Device Lot Number: 161117F9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention