MAUDE Adverse Event Report: PENUMBRA, INC. POD4; HCG, KRD

Catalog Number RBYPOD4

Device Problems Bent (1059); Failure to Advance (2524)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2017

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.This report is associated with mfr report number: 3005168196-2017-02252.The hospital discarded the device.

Event Description

The patient was undergoing a coil embolization procedure using pod4s.During the procedure, after advancing a pod4 approximately two centimeters out of a px slim delivery microcatheter (px slim) and into the target vessel, the physician wanted to retract the pod4 back into px slim for repositioning.However, resistance was encountered and the physician tried to advance the pod4 but also felt resistance.Therefore, the physician removed the px slim and the pod4 altogether.While attempting to advance the pod4 on the back table, the physician noticed that the coil was detached.The hospital technologist opened a new pod4 and attempted to advance on the back table for verification; however, the pod4 was stuck in its introducer and upon pushing hard, the pod4 pusher assembly became bent.Therefore, the second pod4 was set aside and the procedure was completed using a ruby coil and the same px slim.There was no report of an adverse effect to the patient.

• Brand Name: POD4
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7135890
• MDR Text Key: 95794438
• Report Number: 3005168196-2017-02253
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F77814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1