MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 8; DXE

Catalog Number SEP8

Device Problem Break (1069)

Patient Problems Cardiac Arrest (1762); Hemoptysis (1887); Device Embedded In Tissue or Plaque (3165)

Event Date 02/18/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).Death is a known and anticipated complication with these types of procedures and are noted in the device labeling for the indigo aspiration system.The product was not returned for evaluation.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 thrombectomy procedure in the bilateral pulmonary arteries using an indigo system separator 8 (sep8).During the procedure, the physician used the sep8 with the indigo system aspiration catheter 8 (cat8) and a non-penumbra sheath for approximately 10 minutes and the tip of the sep8 inadvertently broke off in the right pulmonary.No attempts were made to retrieve the broken tip of the sep8.The physician then inserted the cat8 with a new sep8 into the left pulmonary artery.However, after 5 minutes into the procedure of the left pulmonary artery, the patient experienced hemoptysis.The patient was intubated and went into cardiac arrest.Tissue plasminogen activator (tpa) was given between switching from the right pulmonary artery to the left pulmonary artery.Subsequently, the patient expired.It is uncertain if the hemoptysis and the cardiac arrest are related to the sep8.

Manufacturer Narrative

Please note that additional information was provided on 19 mar 2019, as this complaint was submitted to the fda by the user facility with the following reference number: (b)(4).Please note that the following section has been updated accordingly:.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8438667
• MDR Text Key: 139406917
• Report Number: 3005168196-2019-00500
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548017440
• UDI-Public: 00814548017440
• Combination Product (y/n): Y
• PMA/PMN Number: K161523
• 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: 01/01/2005,02/18/2019

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 Expiration Date: 09/05/2021
• Device Catalogue Number: SEP8
• Device Lot Number: F85724
• 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: 02/18/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 03/19/2019
• Supplement Dates FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 64