PENUMBRA SYSTEM JETD REPERFUSION CATHETER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for PENUMBRA SYSTEM JETD REPERFUSION CATHETER manufactured by Penumbra, Inc..

Event Text Entries

[184417916] 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, inability to completely remove thrombus, intracranial hemorrhage, distal embolization, neurological deficits including stroke, 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. Additional 510(k)#s that also apply to this complaint: k133317.
Patient Sequence No: 1, Text Type: N, H10

[184417917] On (b)(6) 2019, the patient underwent a thrombectomy procedure in the m2 segment of the middle cerebral artery (mca) using a penumbra system jetd reperfusion catheter (jetd). It was reported that the patient presented to the emergency room for new onset of atrial fibrillation (afib) with rapid ventricular rate (rvr), developed right facial droop, and right hemiparesis. During the procedure, there were no reported complications, and a thrombolysis in cerebral infarction (tici) grade 2b recanalization was achieved. Pre-procedure, the patient had a national institutes of health stroke scale (nihss) of seven. Twenty-four hours post-procedure on (b)(6) 2019, the patient had a nihss of thirteen. On (b)(6) 2019, a repeat computed tomography (ct) scan showed new small right corona radiata hemorrhage. On (b)(6) 2019, the patient expired. The patient's death was adjudicated to be a serious adverse event related to the jetd.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3005168196-2020-00422
• MDR Report Key: 9862831
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-03-20
• Date of Report: 2020-02-24
• Date of Event: 2019-04-11
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-02-24
• Date Added to Maude: 2020-03-20
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. VERONICA FARRIS
• Manufacturer Street: ONE PENUMBRA PLACE
• Manufacturer City: ALAMEDA CA 94502
• Manufacturer Country: US
• Manufacturer Postal: 94502
• Manufacturer Phone: 5107483200
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: PENUMBRA SYSTEM JETD REPERFUSION CATHETER
• Generic Name: NRY
• Product Code: NRY
• Date Received: 2020-03-20
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PENUMBRA, INC.
• Manufacturer Address: ONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-03-20
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2020-03-20