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

Catalog Number	RBY2C2060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Blood Loss (2597)
Date of Event	01/29/2019
Type of Reportable Event	Death
Additional 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: 3005168196-2019-00379.
Event or Problem 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: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8381056
• Report Number: 3005168196-2019-00380
• Device Sequence Number: 2029667
• Product Code: HCG
• UDI-Device Identifier: 00814548019284
• UDI-Public: 00814548019284
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/30/2019
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2026
• Device Catalogue Number: RBY2C2060
• Device Lot Number: F84573
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 50 YR
• Date Report Sent to FDA: 01/01/2005