MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM; CATHETER, THROMBUS RETRIEVER

Model Number	5MAXJET7KIT-B
Health Effect - Clinical Codes	Death (1802); Fistula (1862); Hemorrhage/Blood Loss/Bleeding (1888); Ischemia Stroke (4418)
Date of Event	10/29/2020
Type of Reportable Event	Death
Event or Problem Description
Doctor noted that patient had a left middle cerebral artery (m1 segment) reocclusion demonstrated via cerebral angiography.Using the penumbra jet¿ 7 reperfusion catheter + penumbra hi-flow tubing ( model: 5maxjet7kit-b), doctor made 3 passes and was unable to open the artery.When doctor removed the catheter, he found that the catheter had unraveled.The internal metal of the catheter was unraveled near the end of the catheter and exposed, but the actual tip was intact.Using another catheter, he examined the artery and the unraveled catheter had caused a carotid cavernous fistula, and bleeding from the carotid artery.To stop the bleeding, he performed a left carotid take down with coils which essentially cut off blood flow to the left side of the brain.Left hemispheric ischemic stroke progressed and eventually caused a midline shift.Patient was given comfort care and allowed to pass peacefully.Patient died two days later.
Event or Problem Description
Doctor noted that patient had a left middle cerebral artery (m1 segment) reocclusion demonstrated via cerebral angiography.Using the penumbra jet¿ 7 reperfusion catheter + penumbra hi-flow tubing ( model: 5maxjet7kit-b), doctor made 3 passes and was unable to open the artery.When doctor removed the catheter, he found that the catheter had unraveled.The internal metal of the catheter was unraveled near the end of the catheter and exposed, but the actual tip was intact.Using another catheter, he examined the artery and the unraveled catheter had caused a carotid cavernous fistula, and bleeding from the carotid artery.To stop the bleeding, he performed a left carotid take down with coils which essentially cut off blood flow to the left side of the brain.Left hemispheric ischemic stroke progressed and eventually caused a midline shift.Patient was given comfort care and allowed to pass peacefully.Patient died two days later.

• Brand Name: PENUMBRA SYSTEM
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10850869
• Report Number: 10850869
• Device Sequence Number: 3217614
• Product Code: NRY
• UDI-Device Identifier: 00815948020962
• UDI-Public: (01)00815948020962
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020
• Report Date (Section F): 11/04/2020

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
• Operator of Device: Health Professional
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F95679
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 11/23/2020
• 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: Death; Life Threatening; Required Intervention
• Patient Weight: 75
• Date Report Sent to FDA: 11/04/2020