MAUDE Adverse Event Report: PENUMBRA, INC. POD; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number RBYPOD6

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 05/19/2022

Event Type  malfunction  

Event Description

Surgeon attempted to put pod6 coil in the inferior mesenteric artery.The wire broke as he put the coil, the coil was removed successfully, and kept to be given to the nurse manager.

• Brand Name: POD
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 15282483
• MDR Text Key: 298472824
• Report Number: 15282483
• 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: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBYPOD6
• Device Lot Number: F113312
• 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: 08/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA
• Patient Weight: 110 KG