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

Catalog Number CAT8XTORQ115-C

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

Patient Problems Death (1802); Hemoptysis (1887); Ventricular Tachycardia (2132)

Event Date 12/18/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 numbers: 3005168196-2019-00104; 3005168196-2019-00105.

Event Description

On (b)(6) 2018, the patient underwent a thrombectomy procedure in the right and left pulmonary artery using an indigo system aspiration catheter 8 (cat8) and an indigo system separator 8 (sep8).It was noted that a left-sided pulmonary angiogram disclosed an occlusion of the proximal portion of the main pulmonary artery and a right-sided pulmonary angiogram disclosed significant superior and inferior, as well as, mid branch occlusions.The thrombectomy in the right pulmonary artery was completed with good results using a sep8 and a cat8.Upon removal of the sep8, the physician noticed that the tip of the sep8 was bent.Another thrombectomy was then completed in the left pulmonary artery with good angiographic results using a second sep8 and the same cat8.However, a perforation was noticed on the distal branch of the inferior left pulmonary artery which caused a pulmonary hemorrhage.The patient's respiration declined and the patient was intubated and transferred to the intensive care unit.A bronchial blocker was inserted via endotracheal tube with bronchoscopic guidance into the proximal bronchus of the lower lobe, where the pulmonary hemorrhage bleeding was identified and controlled.The patient then developed acute blood loss anemia, related to the pulmonary hemorrhage and the bleeding from the femoral arterial sheath removal.Therefore, packed red blood cells (prbc) were transfused emergently.The patient was then stable, the oxygen requirement was decreased to 60% on the ventilator, and heparin was restarted.Approximately eight hours post-procedure, the patient went into sustained ventricular tachycardia and ventricular fibrillation, most likely related to the ischemic right ventricle.The patient remained hemodynamically stable until an onset of arrhythmia.Cardiopulmonary resuscitation (cpr) was performed, but was not successful.The patient experienced hemoptysis after cpr began.Subsequently, the patient expired from ventricular tachycardia.The hemoptysis was reported to be a serious adverse event with a possible relationship to the indigo system and the index procedure.The sustained ventricular tachycardia was reported to be a serious adverse event with a possible relationship 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 8259664
• MDR Text Key: 133459335
• Report Number: 3005168196-2019-00117
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,12/18/2018

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: 02/06/2021
• Device Catalogue Number: CAT8XTORQ115-C
• Device Lot Number: C06070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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: 12/18/2018
• Initial Date FDA Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR