MAUDE Adverse Event Report: PENUMBRA, INC. POD8; HCG, KRD

Model Number RBYPOD8

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

The product was disposed of by the hospital and is no longer available for return.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a coil embolization procedure in the hypogastric artery using pod8s.During the procedure, while attempting to advance a pod8 through a lantern delivery microcatheter (lantern), the hospital technologist accidentally pushed too hard and kinked the pod8 pusher assembly; therefore, it was removed.The procedure was completed using a ruby coil and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: POD8
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7421828
• MDR Text Key: 105264206
• Report Number: 3005168196-2018-00750
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (y/n): Y
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/14/2018

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 Expiration Date: 06/02/2022
• Device Model Number: RBYPOD8
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F43683
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/11/2018
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR