MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME FRAMING COIL 10-AV; EMBOLIZATION COIL

Model Number 100510HFRM-V-A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.The device has not yet been returned to the manufacturer.The investigation is currently underway.

Event Description

It was reported that during repositioning of a hydroframe coil in an aneurysm, the coil unexpectedly detached inside the microcatheter without use of the v-grip detachment controller.The coil was safely removed from the patient.There was no reported intervention.There was no reported patient injury, and the patient was reported to be okay at hospital discharge.

Manufacturer Narrative

The device was received inside the introducer; however, the microcathter was not returned for evaluation.The implant coil was noted to be detached from the pusher, and the proximal end was stretched.The monofilament had striations and a tail.The gold connector had a kink in the e3 location.The resistance was measured, and noted to be within specifications.The v-grip test passed in all orientation.Based on the investigation and provided information, the complaint can be confirmed.The specific root cause of this complaint is not known, although the device exhibits evidence that the monofilament was subjected to forces that exceeded its strength specifications.

• Brand Name: HYDROFRAME FRAMING COIL 10-AV
• 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: 6397341
• MDR Text Key: 69752858
• Report Number: 2032493-2017-00062
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00811425027080
• UDI-Public: (01)00811425027080(11)151104(17)201104(10)151104F1
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/04/2020
• Device Model Number: 100510HFRM-V-A
• Device Lot Number: 151104F1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2015
• 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 Age: 54 YR