MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET7 REPERFUSION CATHETER NRY

Model Number 5MAXJET7KIT-B

Device Problem Break (1069)

Patient Problems Death (1802); Intracranial Hemorrhage (1891); Device Embedded In Tissue or Plaque (3165)

Event Date 09/04/2019

Event Type  Death  

Manufacturer Narrative

This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system jet7 kit (kit). During the procedure, the physician advanced the penumbra system jet 7 reperfusion catheter (jet7) over a non-penumbra guidewire up to the m1 occlusion through a neuron max 6f 088 long sheath (neuron max). Next, the physician advanced the jet7 to the clot and turned on aspiration; however, after approximately two minutes, there was no flow of blood in the aspiration tubing. Therefore, the physician started to retract the jet7. Upon reaching the internal carotid artery (ica) terminus, the physician noticed that blood flow started to come through the aspiration tubing and, subsequently, observed that the vessel had recanalized. After removing the jet7, it noticed that the coils at the distal tip of the jet7 were ¿unwound¿ and frayed. The physician then performed a contrast run and noticed a hemorrhage just distal to the ica terminus where the distal tip of the jet7 had broken off and seated. No attempts were made to retrieve the broken tip and the physician ended the procedure at this point. Subsequently, the patient expired; however, the cause of death is unknown at this time. Furthermore, the relationship between the fractured jet7 tip and death is unknown.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Type of Device: NRY
• 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: 9151990
• MDR Text Key: 161185471
• Report Number: 3005168196-2019-01851
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948020962
• UDI-Public: 00815948020962
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/01/2005,09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/28/2022
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: C16175
• 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
• Event Location: No Information
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 10/03/2019 Patient Sequence Number: 1