MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number RBY2C1260-B

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fistula (1862); Foreign Body In Patient (2687)

Event Date 08/17/2022

Event Type  malfunction  

Event Description

Av fistula dislodged into the ventricle and had to be retrieved.

• Brand Name: RUBY COIL
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 15470272
• MDR Text Key: 300458296
• Report Number: 15470272
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2022

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 Model Number: RBY2C1260-B
• Device Catalogue Number: RBY2C1260
• Device Lot Number: F95314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2022
• Date Report to Manufacturer: 09/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Sex: Female