MAUDE Adverse Event Report: PENUMBRA RUBY; EMBOLIZATION COIL

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 07/10/2017

Event Type  Injury  

Event Description

While the physician was delivering a ruby embolization coil to embolize a subclavian artery aneurysm, the coil unexpectedly detached without any warning.The physicians had to intervene so that the coil did not permanently stay within the subclavian artery and not the aneurysm.

• Brand Name: RUBY
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): PENUMBRA
• MDR Report Key: 7071462
• MDR Text Key: 93482156
• Report Number: MW5073640
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR