MAUDE Adverse Event Report: PENUMBRA, INC. POD 14; HCG, KRD

Catalog Number RBYPOD14

Device Problem Premature Separation (4045)

Patient Problems Cardiac Arrest (1762); Death (1802); Blood Loss (2597)

Event Date 01/29/2019

Event Type  Death  

Manufacturer Narrative

The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the penumbra system include, but are not limited to, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, ischemia, including death.Therefore, it was determined that the reported adverse events were anticipated complications.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: 3005168196-2019-00380.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using a pod14 and ruby coils.During the procedure, the physician advanced a guidewire into the proximal portion of the target vessel followed by a non-penumbra guide catheter.The physician then advanced a non-penumbra microcatheter over the guidewire into the target location, distal to the pseudoaneurysm, and began embolization.While advancing a pod14 into the target vessel, the pod14 unintentionally detached within the microcatheter.The pod14 was unable to be retrieved from the microcatheter; therefore, the microcatheter was removed.The pod14 remained partially in the guide catheter and partially in the splenic artery beyond the pseudoaneurysm.The pod14 was retrieved from within the guiding catheter using a snare device and was removed intact.After re-accessing the target vessel, the physician performed arteriography demonstrating extravasation of contrast originating from a ruptured proximal splenic arterial pseudoaneurysm.The patient experienced significant blood loss resulting in profound hemodynamic instability, and had no pulse.Cardiac life support and multiple blood transfusions were performed, and the patient¿s pulse was restored.The code team decided to continue endovascular coil embolization.As the physician was advancing a 20x60 ruby coil through the microcatheter, the ruby coil unintentionally detached.A 16x50 ruby coil was then advanced through the microcatheter which pushed the first 20x60 ruby coil out of the microcatheter, resulting in a non target embolization of the hepatic artery.The 20x60 ruby coil was then implanted.As there was still flow through the coil pack in the splenic artery, the microcatheter was advanced over the wire and multiple coils were placed to fill the coil interstices.A celiac artery angiography was performed demonstrating no filling of the common hepatic artery or proximal splenic trunk.The patient was then immediately taken to the operating room (or) for surgery due to compartment syndrome from significant blood loss; however, the patient went into cardiac arrest prior to surgery resulting in death.

• Brand Name: POD 14
• 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: 8381057
• MDR Text Key: 137501961
• Report Number: 3005168196-2019-00379
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548019673
• UDI-Public: 00814548019673
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYPOD14
• Device Lot Number: F84398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 01/30/2019
• Initial Date FDA Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2018
• 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 Outcome(s): Death; Required Intervention
• Patient Age: 50 YR