MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFILL-10 HELICAL; EMBOLIZATION COIL

Model Number MV-00620HFL

Device Problems Detachment Of Device Component (1104); Device-Device Incompatibility (2919)

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

Event Date 02/07/2017

Event Type  Injury  

Manufacturer Narrative

The lot number was provided.A review of the device history records 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 will not be returned for evaluation; therefore, a product analysis could not be performed.The root cause cannot be determined.

Event Description

It was reported that during positioning of an embolization coil, resistance was encountered in the microcatheter less than five minutes or less after the coil had been inserted in the microcatheter.During an attempt to remove the coil, the coil unexpectedly detached in the microcatheter.The detached coil was retrieved with a snare device, and the procedure was completed with other coils.There was no reported patient injury or health damage.

• Brand Name: HYDROFILL-10 HELICAL
• 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: 6398197
• MDR Text Key: 69734369
• Report Number: 2032493-2017-00063
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2017

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
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: MV-00620HFL
• Device Lot Number: 13081449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 03/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2013
• 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