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

Catalog Number RBYPOD4

Device Problems Positioning Failure (1158); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

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.This report is associated with mfr report numbers: 3005168196-2018-00353, 3005168196-2018-00355.

Event Description

The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using pod4's, penumbra coil 400's (pc400's) and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced an initial pod4 through the lantern and attempted to deploy the coil in the target vessel; however, the pod4 was not coiling properly and was removed.While attempting to advance a new pc400 into the same lantern, the physician encountered resistance near the hub of the lantern and decided to remove the pc400.The pc400 was then visually inspected in a tray filled with saline and another attempt was made to advance the coil out of its introducer sheath and into the lantern; however, resistance was still encountered so the pc400 was removed.Next, the physician advanced the initial pod4 through the lantern and into the target vessel but the coil did not coil properly and was removed.In the end, the ima was not embolized with coils and stent grafting was performed.It was reported that the lantern, pod4 and pc400 were slightly damaged but the specific details are unknown.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 (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7272263
• MDR Text Key: 100148492
• Report Number: 3005168196-2018-00354
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F79792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2017
• 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
• Patient Age: 89 YR