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

Model Number RBYPOD6-A

Device Problems Output Problem (3005); Activation Failure (3270)

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

Event Date 09/15/2021

Event Type  malfunction  

Event Description

A coil that was used did not deploy correct.Did not detach from device, was removed from patient and surgical field without event.

• Brand Name: POD
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 13757330
• MDR Text Key: 287129519
• Report Number: 13757330
• 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: 02/01/2022

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 Operator: Health Professional
• Device Model Number: RBYPOD6-A
• Device Catalogue Number: RBYPOD6
• Device Lot Number: F95115
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White