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

Model Number RBYPODJ60

Device Problems Positioning Failure (1158); Defective Device (2588)

Patient Problem No Information (3190)

Event Date 07/11/2017

Event Type  malfunction  

Event Description

Attempted to deploy a penumbra pod packing coil with negative results.The coil did not deploy and was considered defective.Coil was pulled into catheter and both were removed from patient.

• Brand Name: POD
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6759621
• MDR Text Key: 81601489
• Report Number: 6759621
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: RBYPODJ60
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: F76859
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2017
• Event Location: Other
• Date Report to Manufacturer: 07/31/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21 YR