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

Model Number RBYLP0860

Device Problem Difficult to Insert (1316)

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

Event Date 08/22/2020

Event Type  malfunction  

Event Description

Coil could not enter microcatheter (would go past the hub of the catheter).It was found to be defective right before it could be entered the patient's body.

• 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: 10592613
• MDR Text Key: 208747375
• Report Number: 10592613
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: RBYLP0860
• Device Catalogue Number: RBYLP0860
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1