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

Catalog Number CAT8XTORQ115

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

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)

Event Date 03/07/2019

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.Hypotension is a known and anticipated complications with these types of procedures and are noted in the indigo system labeling.Therefore, it was determined that these reported adverse events were anticipated procedural complications.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

On (b)(6) 2019, the patient underwent a thrombectomy procedure in the pulmonary arteries using an indigo system aspiration catheter 8 (cat8).During the procedure, the patient experienced transient episodes of ventricular tachycardia (vt) and supraventricular tachycardia (svt).The patient was then treated with lidocaine during the procedure.This event was resolved on the same day.During the same procedure, it was reported that the patient became hypertensive to 180 mmhg systolic blood pressure and was treated with labetalol.However, immediately after the patient was treated with labetalol, the patient became hypotensive.The patient was then administered epinephrine and vasopressin to treat the hypotension.This event was also resolved on the same day.The patient was discharged home on (b)(6) 2019.The tachycardia and hypertension were adjudicated to be adverse events with a possible relationship to the indigo system and the index procedure.On 23-apr-2019, the cec adjudicated that the transient episodes of vt and svt were unrelated to the indigo system and the index procedure, and related to an index pulmonary embolism.It was also adjudicated that the hypertension was related to the indigo system, index procedure, and the index pulmonary embolism.

Manufacturer Narrative

Please note that the following sections are being updated based on additional information provided by a penumbra medical affairs associate on (b)(6) 2019: 1.Section b.Box 5.Describe event or problem.

Event Description

On (b)(6) 2019, the patient underwent a thrombectomy procedure in the pulmonary arteries using an indigo system aspiration catheter 8 (cat8).During the procedure, the patient experienced transient episodes of ventricular tachycardia (vt) and supraventricular tachycardia (svt).The patient was then treated with lidocaine during the procedure.This event was resolved on the same day.During the same procedure, it was reported that the patient became hypertensive to 180 mmhg systolic blood pressure and was treated with labetalol.However, immediately after the patient was treated with labetalol, the patient became hypotensive.The patient was then administered epinephrine and vasopressin to treat the hypotension.This event was also resolved on the same day.The patient was discharged home on (b)(6) 2019.The tachycardia and hypertension were adjudicated to be adverse events with a possible relationship to the indigo system and the index procedure.On (b)(6) 2019, the cec adjudicated that the transient episodes of vt and svt were unrelated to the indigo system and the index procedure, and related to an index pulmonary embolism.It was also adjudicated that the hypertension was related to the indigo system, index procedure, and the index pulmonary embolism.On (b)(6) 2019, the cec adjudicated that there was only a single adverse event (hemodynamic instability) for this subject and is not related to the indigo system and the index procedure.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8578049
• MDR Text Key: 143981644
• Report Number: 3005168196-2019-00852
• 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: 01/01/2005,04/03/2019

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: 05/10/2020
• Device Catalogue Number: CAT8XTORQ115
• Device Lot Number: C01701
• 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: 04/03/2019
• Initial Date FDA Received: 05/03/2019
• Supplement Dates Manufacturer Received: 06/12/2019
• Supplement Dates FDA Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR