MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET7 REPERFUSION CATHETER; HCG, KRD

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

Patient Problem Vasoconstriction (2126)

Event Date 07/12/2020

Event Type  malfunction  

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.Potential adverse events in the labeling with the penumbra system include, but are not limited to, hematoma or hemorrhage at the site,vessel spasm, inability to completely remove thrombus, intracranial hemorrhage, ischemia, including death.Therefore, it was determined that the reported adverse events were anticipated complications.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

On (b)(6) 2020, the patient underwent a thrombectomy procedure in the right middle cerebral artery (mca) and right internal carotid artery (ica) using a penumbra system jet 7 reperfusion catheter (jet7).During the procedure, the physician completed two passes using the jet7.Afterwards, the physician performed a digital subtraction angiography (dsa) through the jet7 in the right internal carotid artery (ica) resulting thrombolysis in cerebral infarction (tici) 3; however, the physician noticed vasospasm in the right mca.The physician infused 10mg of intra-arterial verapamil through the jet7 in the right ica using a slow hand bolus technique over approximately 10 minutes.Post verapamil infusion, the physician performed another digital subtraction angiography (dsa) showing correction of the vasospasm.The event was considered resolved the same day with the infusion of verapamil.The vasospasm was reported to be a non-serious adverse event with a definite relationship to the index procedure and jet7.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Type of Device: HCG, KRD
• 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: 11405450
• MDR Text Key: 241504051
• Report Number: 3005168196-2021-00392
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K173761
• 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: 01/01/2005,02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention