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

Catalog Number	CAT8STR85
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyanosis (1798); High Blood Pressure/ Hypertension (1908); Hypoxia (1918)
Date of Event	01/24/2016
Type of Reportable Event	Serious Injury
Additional 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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.The device is not available for return.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an extensive bilateral pulmonary emboli using an indigo system aspiration catheter 8 (cat8).During the procedure, the physician advanced a non-penumbra sheath with a non-penumbra guide wire into the left main pulmonary artery.Next, the physician placed a guide catheter over a 0.035" guidewire and then exchanged the vascular sheath for a long guiding sheath over a 0.035" guidewire.Thereafter, the physician advanced the cat8 through the sheath and performed several passes.However, the post mechanical thrombectomy pulmonary angiogram study revealed a lack of response to the thrombectomy even after several passes.Subsequently, a decision was made to continue the procedure with a catheter directed thrombolysis utilizing an ultrasonic assisted thrombolytic catheter (i.E.Ekos).Therefore, a lytic catheter was advanced into the left pulmonary artery and the physician used a non-penumbra catheter to select the right main pulmonary artery.A thrombolytic catheter was then advanced along the right pulmonary artery.Tissue plasminogen activator (tpa) was scheduled to be infused through the catheter and heparin was scheduled to be infused in each side arm of the femoral venous sheath.The patient was then transferred to the intensive care unit for strict observation.On (b)(6) 2016, the patient was discharged.During the thrombectomy procedure, the patient developed facial cyanosis and severe hypoxia with oxygen saturation down to 78%.The patient also experienced rigors and chills and was immediately intubated with an endotracheal tube.The position of the endotracheal tube was checked with fluoroscopy.The patient''s blood pressure was also abnormal in the range of 210 mm mercury systolic and was given lopressor intravenously.The reported hypoxia, hypertension and mechanical intubation were adjudicated to be serious adverse events possibly related to the cat8.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6953630
• Report Number: 3005168196-2017-01778
• Device Sequence Number: 11015732
• Product Code: DXE
• UDI-Device Identifier: 00814548016269
• UDI-Public: 00814548016269
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2017

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
• Operator of Device: Physician
• Device Catalogue Number: CAT8STR85
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other; Required Intervention
• Patient Age: 61 YR