MAUDE Adverse Event Report: PENUMBRA, INC. LP COIL SYSTEM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number RBYLP0415

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 11/18/2020

Event Type  malfunction  

Event Description

Ruby coil lp, 4 mm x 15 cm would not deploy.Second lp coil system obtained and case continued without incident.No harm to patient.The faulty ruby lp coil system was returned to the vendor.

Event Description

Ruby coil lp, 4 mm x 15 cm would not deploy.Second lp coil system obtained and case continued without incident.No harm to patient.The faulty ruby lp coil system was returned to the vendor.

• Brand Name: LP COIL SYSTEM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): PENUMBRA, INC.; 6262 patterson pass rd; suite a; livermore CA 94550
• MDR Report Key: 11162880
• MDR Text Key: 226619853
• Report Number: 11162880
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

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: No Information
• Device Model Number: RBYLP0415
• Device Lot Number: F97177
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2021
• Date Report to Manufacturer: 01/13/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26280 DA