MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN CLARITY; CATHETER, FLOW DIRECTED

Model Number 6225I

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.Product event summary: the balloon catheter was returned and analyzed.The mechanical operation of the catheter was analyzed, and the balloon catheter was occluded.The analyst noted the syringe was not returned.A fresh syringe was used to attempt to inflate the balloon.The balloon does not inflate and there is blood visible in the balloon.There was clear dried substance visible inside the balloon-syringe port, likely contrast.(b)(4).

Event Description

It was reported that during the coronary sinus catheterism, the physician used the balloon catheter for the venogram.The physician noted that it was impossible to deflate the balloon after injection.The balloon catheter was removed with excessive strength.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN CLARITY
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5119999
• MDR Text Key: 27557087
• Report Number: 9612164-2015-01589
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2016
• Device Model Number: 6225I
• Device Catalogue Number: 6225I
• Device Lot Number: 0007386056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2014
• 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