MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKPROWLER; MICROCATHETER

Catalog Number UNKPROWLER

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

Patient Problem Embolism/Embolus (4438)

Event Date 05/01/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).Literature citation: liang g, gao x, li z, wei x, xue h.Neuroform stent-assisted coiling of intracranial aneurysms: a 5 year single-center experience and follow-up.Neurol res.2010 sep;32(7):721-7.Doi: 10.1179/016164109x12445616596409.Epub 2009 aug 5.Pmid: 19660196.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

This complaint is from a literature source and the following literature citation was reviewed: liang g, gao x, li z, wei x, xue h.Neuroform stent-assisted coiling of intracranial aneurysms: a 5 year single-center experience and follow-up.Neurol res.2010 sep;32(7):721-7.Doi: 10.1179/016164109x12445616596409.Epub 2009 aug 5.Pmid: 19660196.Objective and methods: the authors report their clinical experience and 5 year follow-up results using neuroform stent, as an adjunct in the treatment of wide-necked and fusiform aneurysms.A 6f or 8f sheath was introduced in the right femoral artery following a standard seldinger puncture.A 6f or 8f envoy guiding catheter was then guided into either the cervical internal carotid or vertebral artery, depending on the location of the aneurysm.The microcatheters were prowler or excelsior sl-10.Sequential or parallel techniques were utilized.Coil manufacturers were not identified.Procedures were performed on ruptured and unruptured aneurysms.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: 6f or 8f envoy guiding catheter, prowler microcatheter other cerenovus devices that were also used in this study: n/a non-cerenovus devices that were also used in this study: neuroform stent system - wire & stent(boston scientific/target), excelsior sl-10 microcatheter (boston scientific/target) exact quantities cannot be determined as the article does not provide sufficient information to determine quantities.Article does not specify which microcatheters or other medical devices were associated with the listed adverse event(s).Adverse event(s) and provided interventions: qty 4 thromboembolism treated by local intra-artery administration of abciximab and urokinase and mechanical disruption of clot with microwire.

• Brand Name: UNKPROWLER
• Type of Device: MICROCATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 12573720
• MDR Text Key: 281443168
• Report Number: 3008114965-2021-00495
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K003925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKPROWLER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention