INDIGO ASPIRATION SYSTEM
Received Jul 8, 2026 · Event occurred Jun 8, 2026
Report 3005168196-2026-00229 · MDR key 25752152
Device
Generic name
Qew
Manufacturer
Penumbra, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
80 YR · Female
- Low Blood Pressure/ Hypotension
Narrative
Additional Manufacturer Narrative
THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THEREFORE, A PHYSICAL DEVICE INVESTIGATION WAS UNABLE TO BE PERFORMED. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.
Description of Event or Problem
THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING AN INDIGO ASPIRATION SYSTEM (UNKNOWN). DURING THE PROCEDURE, THE PATIENT WAS STARTED ON NORADRENALINE AT 0.25 G/KG/MIN, WHICH WAS REDUCED TO 0.125 G/KG/MIN BY THE END OF THE CASE. IT WAS REPORTED THAT DURING TRANSPORTATION TO THE WARD, VENOUS ACCESS WAS LOST. AFTER RETURNING TO THE WARD FOLLOWING THE PROCEDURE, THE PATIENT¿S BLOOD PRESSURE DROPPED TO 70/40 MMHG AT 5:20 PM. A CENTRAL CATHETER WAS PLACED TO RESTORE VENOUS ACCESS. THE PATIENT WAS THEN ADMINISTERED MEDICATION (NORADRENALINE), RESULTING IN RESTORATION OF BLOOD PRESSURE. THE EVENT IS CONSIDERED RESOLVED. THE HYPOTENSION WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDIGO ASPIRATION SYSTEM AND A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE.