MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC INTERLOCK VERTEX FIBERED MICROCOIL; VERTEX RETRIEVABLE COIL

Model Number 36-176

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Malposition of Device (2616); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 03/04/2014

Event Type  Injury  

Event Description

While inserting an interlock 2mm x 5mm vertex retrievable.Coil by the physician in interventional radiology.The physician was not pleased with the position of the coil was going.He then decided to pull the coil out and not deploy it.Once the coil was pulled out, he viewed with a fluoroscope and the coil had become detached and left in an undesirable location.The physician tried to retrieve the coil via three different snare devices and was unsuccessful.The pt was then sent to surgery.Diagnosis or reason for use: this equipment was used to occlude the pseudoaneurysm.

• Brand Name: BOSTON SCIENTIFIC INTERLOCK VERTEX FIBERED MICROCOIL
• Type of Device: VERTEX RETRIEVABLE COIL
• Manufacturer (Section D): BOSTON SCIENTIFIC; one scimed place; maple grove MN 55311
• MDR Report Key: 3685283
• MDR Text Key: 4297492
• Report Number: MW5034951
• Device Sequence Number: 1
• Product Code: HCG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2014
• Device Model Number: 36-176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR