MAUDE Adverse Event Report: PULSAR VASCULAR UNKPULSERIDER; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKPULSERIDER

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

Patient Problems Vasoconstriction (2126); No Patient Involvement (2645)

Event Date 06/30/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿use of the pulserider device in the treatment of ruptured intracranial aneurysms: a case series¿ (pmid: 30862588).A (b)(6) female patient with a ruptured wide-necked basilar tip aneurysm who underwent pulserider-assisted coil embolization experienced vasospasm present on postbleed day 5 and underwent dsa (digital subtraction angiography) with intra-arterial verapamil administration a total of 7 times during her course.The aim of this study was to report a small but promising series of successful use of the pulserider device in the acute treatment of wide-necked, ruptured basilar artery aneurysms.Methods: between march and june 2018, we treated 4 cases of ruptured wide-necked basilar tip aneurysms at the university of colorado hospital, aurora, colorado, with pulserider-assisted coil embolization.Imaging and chart.Pulserider device was used in this study.No devices specific information (including catalog and lot number) were provided in the article.".

Manufacturer Narrative

This complaint has been identified as a duplicate of (b)(4).Codes have been updated to no alleged quality issue, no adverse event, no patient involvement to prevent duplicate coding of the same event.Initial report: mwr: (b)(4) has been detected as a duplicate of mwr: (b)(4).All information and investigation was documented under mwr: (b)(4).

• Brand Name: UNKPULSERIDER
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): PULSAR VASCULAR; 130 knowles dr suite e; los gatos CA 95032
• MDR Report Key: 9430425
• MDR Text Key: 185753744
• Report Number: 3008680601-2019-00575
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKPULSERIDER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR