MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER; DXE

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

Patient Problem Anemia (1706)

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

On (b)(6) 2021, the patient underwent a thrombectomy procedure using an indigo system catheter.It was reported the patient had previous intervention on the affected limb.Post-procedure, blood loss hemoglobin (hgb) dropped to 11.2 and continued to drop as low as 6.5 on (b)(6) 2021.Transfusion of packed red blood cells was ordered and given on (b)(6) 2021.The event is ongoing.The anemia was reported to be a serious adverse event with a definite relationship to the indigo system and index procedure.

Manufacturer Narrative

Please note that the following section was updated based on additional information provided by penumbra medical affairs associate on 27 apr 21: section b.Box 5.Describe event or problem.

Event Description

As of 27-april 21, the serious adverse event of acute surgical blood loss anemia/access site hemorrhage was unrelated to the indigo system and related to the index procedure.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11668083
• MDR Text Key: 245491947
• Report Number: 3005168196-2021-00753
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): Y
• PMA/PMN Number: K160533
• 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: 01/01/2005,03/16/2021

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
• Was Device Available for Evaluation?: 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: 03/16/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR