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

Catalog Number SEP8

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemoptysis (1887)

Event Date 01/22/2019

Event Type  Injury  

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.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: 3005168196-2019-00386.

Event Description

On (b)(6) 2019, the patient underwent a thrombectomy procedure using an indigo system aspiration catheter 8 (cat8) and an indigo system separator 8 (sep8).During post procedural recovery, the patient began coughing up blood with clots and experienced hemoptysis.The patient¿s heparin drip was discontinued, and the hemoptysis was resolved on (b)(6) 2019.The hemoptysis was reported to be a non-serious adverse event with a definite relationship to the indigo system and a definite relationship to the procedure.

Manufacturer Narrative

Please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 03/01/2019:- age at time of event & age unit, sex, ''other'' reason for non-evaluation, method code added.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8383111
• MDR Text Key: 137593861
• Report Number: 3005168196-2019-00387
• Device Sequence Number: 1
• Product Code: DXE
• 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: 01/01/2005,01/31/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2021
• Device Catalogue Number: SEP8
• Device Lot Number: C11208
• 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: 01/31/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 03/01/2019
• Supplement Dates FDA Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR