MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 10/25/2019

Event Type  Injury  

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 with the penumbra system include intracranial hemorrhage, acute occlusion, death, device malfunction, emboli, hematoma or hemorrhage at the site, inability to completely remove thrombus, ischemia, dissection or perforation and are included in the labeling.Therefore, it was determined that the reported symptomatic intracranial hemorrhage was an anticipated complication.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2019-02307.

Event Description

A report from (b)(6) was received on november 15th, 2019.The patient was undergoing a thrombectomy procedure using a neuron max 6f 088 long sheath (neuron max), penumbra system ace 68 reperfusion catheter (ace68) and two stent retriever devices (solitaire).During the procedure, the patient suffered a symptomatic intracerebral hemorrhage.It was reported that the symptomatic intracerebral hemorrhage does not appear to be related to the research but to one or more of the products used during the procedure.No further information is available.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Type of Device: DQY
• 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: 9462083
• MDR Text Key: 170737139
• Report Number: 3005168196-2019-02306
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/01/2005,11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening