MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL; DEVICE, NEURUVASCULAR EMBOLIZATION

Catalog Number RBYPCLP60

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  malfunction  

Event Description

During an embolization of a gi bleed, unable to deploy lp ruby coil.Fda safety report id# (b)(4).

• Brand Name: RUBY COIL
• Type of Device: DEVICE, NEURUVASCULAR EMBOLIZATION
• Manufacturer (Section D): PENUMBRA, INC. ; alameda CA 94502
• MDR Report Key: 12275465
• MDR Text Key: 265158564
• Report Number: MW5102958
• Device Sequence Number: 1
• Product Code: HCG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/30/2021

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: Health Professional
• Device Catalogue Number: RBYPCLP60
• Device Lot Number: F104027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2021
• 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 Age: 78 YR
• Patient Weight: 86