MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 14MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0036181450

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

This is the 1 of 2 reports.The subject device is not available.

Event Description

During the coil embolization procedure, it was reported that the resistance was felt when advancing the subject coil in the microcatheter.So the physician removed the coil and the coil was prematurely detached in the microcatheter.Then the detached coil was removed together with the microcatheter.The same event also happened to another coil used in the procedure.No clinical consequences reported to the patient.

Manufacturer Narrative

Expiration date: added.Manufacturing date: added.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Information available indicated that the device was confirmed to be in good condition prior to use and the device was prepared as per the dfu.Based on the information currently available the exact cause for the reported main coil prematurely detached inside patient cannot be determined.

Event Description

During the coil embolization procedure, it was reported that the resistance was felt when advancing the subject coil in the microcatheter.So the physician removed the coil and the coil was prematurely detached in the microcatheter.Then the detached coil was removed together with the microcatheter.The same event also happened to another coil used in the procedure.No clinical consequences reported to the patient.

• Brand Name: TARGET XXL 360 14MM X 50CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 7127816
• MDR Text Key: 95241682
• Report Number: 3008881809-2017-00525
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K161429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: M0036181450
• Device Lot Number: 19653071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2017
• 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
• Treatment: SL-10 MICROCATHETER (STRYKER)
• Patient Age: 54 YR