MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER UNK GUIDE CATHETER; CATHETER, PERCUTANEOUS

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

Patient Problems Stroke/CVA (1770); Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 05/01/2003

Event Type  Injury  

Manufacturer Narrative

Journal article: safety, feasibility and efficacy of transradial primary angioplasty in patients with acute myocardial infarction year: 2003 ref: www.Federcardio.It/pdf/2003/05/20030117.Pdf age or date of birth: average age.Sex: majority gender.Date: of event: date of publication.Death was reported as a clinical outcome of this study, however there is no information to suggest the device has caused or contributed to a death.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article titled - safety, feasibility and efficacy of transradial primary angioplasty in patients with acute myocardial infarction - was submitted for review.This article aimed to investigate the safety, feasibility and efficacy of transradial primary percutaneous coronary intervention (pci) in patients with acute myocardial infarction (ami).Adverse clinical events (including death, ventricular arrhythmias, reinfarction, recurrent angina, target lesion revascularization and heart failure) were evaluated during the in-hospital follow-up.A total of 726 patients were enrolled in the study.Of these 163 procedures were performed via the right transradial approach (group a) and 563 were done via the transfemoral approach (group b) for comparison.A medtronic 6fr launcher guide catheter was amongst the devices used during the procedures.Right radial access was achieved in all patients in group a, except 2 who were switched to a right femoral approach and 7 switched to a left radial approach because no adequate guiding position could be obtained from the right radial artery.This was attributed to the tortuosity of the brachycephalic artery.No procedure performed through the radial artery was associated with inadequate support of the guiding catheter.Severe hemorrhagic complications occurred in a number of patients.Two of these patients developed a hemorrhagic stroke at 10 and 14 hours after coronary angioplasty.Two others developed cardiac tamponade and the other three had large hematomas at the puncture site.These complications necessitated a longer length of hospitalization and two of these patients required transfusion.Access site bleeding occurred in eleven patients.In hospital death occurred in eleven patients.Two patients presented with post-infarction angina.Five presented with life-threatening ventricular arrhythmias.The incidence of major bleeding complications after the use of 6f guiding catheters by the femoral approach was deemed to be low.

• Brand Name: LAUNCHER UNK GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 12719825
• MDR Text Key: 281658894
• Report Number: 1220452-2021-00069
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K132673
• 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: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR