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

Catalog Number LAUNCHER(UNK)

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

Patient Problem Death (1802)

Event Date 07/27/2016

Event Type  Death  

Manufacturer Narrative

Literature reference: doi: 10.1002/ccd.26773.If information is provided in the future, a supplemental report will be issued.

Event Description

In a study of 60 patients, 7f launcher guide catheters were used in complex transradial pci procedures.The primary endpoint was procedural success which was defined as completion of the planned procedure through the initially selected radial access route.There were two procedural failures: one case of unsuccessful cto-pci of the right coronary artery and one case requiring conversion to femoral access due to the presence of extreme subclavian tortuosities.There were three vascular access-site complications including two type ii hematomas and one uncomplicated guide catheter-induced brachial dissection.The occurrence of radial spasm was reported in seven patients.Doppler ultra-sound imaging of the radial artery at 1 month was available in 62 out of 64 radial access with three documented cases of radial artery occlusion.One patient was lost to follow-up and another patient died from cardiovascular cause after hospital discharge, but before 1-month follow-up.

• Brand Name: LAUNCHER UNK GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7662144
• MDR Text Key: 113148929
• Report Number: 1220452-2018-00084
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K022764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LAUNCHER(UNK)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 83