PULSERIDER T, 3MM, 10MM ARCH 211-D 211DCT

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 2020-02-07 for PULSERIDER T, 3MM, 10MM ARCH 211-D 211DCT manufactured by Pulsar Vascular.

MAUDE Entry Details

• Report Number: 3008680601-2020-00001
• MDR Report Key: 9683850
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-02-07
• Date of Report: 2020-01-21
• Date of Event: 2019-05-23
• Date Mfgr Received: 2020-01-21
• Device Manufacturer Date: 2016-03-03
• Date Added to Maude: 2020-02-07
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. GABRIEL ALFAGEME
• Manufacturer Street: 31 TECHNOLOGY DRIVE
• Manufacturer City: IRVINE CA 92618
• Manufacturer Country: US
• Manufacturer Postal: 92618
• Manufacturer Phone: 949789-868
• Manufacturer G1: PULSAR VASCULAR
• Manufacturer Street: 130 KNOWLES DR SUITE E
• Manufacturer City: LOS GATOS CA 95032
• Manufacturer Country: US
• Manufacturer Postal Code: 95032
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PULSERIDER T, 3MM, 10MM ARCH
• Generic Name: INTRACRANIAL NEUROVASCULAR STENT
• Product Code: NJE
• Date Received: 2020-02-07
• Model Number: 211-D
• Catalog Number: 211DCT
• Lot Number: W2579-36
• Device Expiration Date: 2019-02-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PULSAR VASCULAR
• Manufacturer Address: 130 KNOWLES DR SUITE E LOS GATOS CA 95032 US 95032

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-02-07