MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Catalog Number LA6MPST

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2015

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: received for analysis was one la6mpst guide catheter without original packaging.The catheter was received engaged to a series of adapters and extension lines.A crimp mark was noted on the launcher catheter as reported, 10cm proximal to the tip.During testing the system was slightly pressurized and a major leak was detected immediately at one of the connections.Upon checking the connection while trying to identify the source of the leak, the parts easily broke apart.No tool marks were noted on the connected competitor adaptor.The 6f launcher was then segregated and the tip was blocked with a.072 pin gauge.The launcher was pressurized using an in-house everest inflation device to approximately 140psi with no leak detected.Vacuum was also applied by pulling the plunger of the everest and no air entering the system was noted.The leak at the mentioned connection was the likely path for air to enter the system.(b)(4).

Event Description

It is reported that a great amount of air leaked into coronary artery from a launcher guide catheter when initial angiography was carried out.The physician was attempting to use the launcher guide catheter during a procedure to treat a lesion in a slightly tortuous rca.The lesion had 75-90% stenosis.No abnormalities were noted during device inspection and preparation before the operation.During the operation, the physician engaged the launcher guide catheter with the coronary artery.When initial angiography was carried out the physician noted air leaking into the coronary artery.The physician performed pci paying attention to air purging.When final angiography was performed at the end of pci, the physician confirmed a greater amount of air leakage compared to the initial time.There was no adverse event to the patient.There was no removal difficulty of the relevant device from the patient.The inner lumen of the relevant device was blocked for system check after the operation.This resulted in an indentation about 10cm from the distal tip.Negative pressure was applied by the physician to check the launcher when it was attached to a non-mdt connection.Air leakage was confirmed.

• Brand Name: LAUNCHER 6F GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC INC.; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5235559
• MDR Text Key: 31831246
• Report Number: 1220452-2015-00056
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021256
• 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: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2016
• Device Catalogue Number: LA6MPST
• Device Lot Number: 0007391938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2014
• 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 Age: 00070 YR