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

Model Number 6225I

Device Problems Deflation Problem (1149); Kinked (1339)

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

Event Date 09/10/2015

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, analyzed and there was an issue with the syringe.The catheter was noted to be damaged during use.The analyst noted the returned syringe and balloon catheter had dried clear substance (likely contrast) visible both inside and outside the barrel of the syringe and shaft of balloon and balloon itself.This dried clear substance may have contributed to the initial problem with deflation.There was no kink visible and blood/dried clear substance was visible in the guidewire port.The analyst noted the returned balloon does not inflate due to a cut in the balloon indicating damage during procedure.(b)(4).

Event Description

It was reported that during implant, the balloon catheter failed to deflate upon withdrawal of the syringe.The balloon catheter had to be pulled back with force and was noted to be wedged at the tip of the coronary sinus (cs) catheter.The cs catheter was pulled back and the balloon was inflated into the atrium.The balloon catheter then deflated itself when out of the coronary sinus.In addition, the physician suspects a kink in the balloon catheter.The catheter was removed.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: 5272125
• MDR Text Key: 33100085
• Report Number: 9612164-2015-01822
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Type of Report: Initial
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2016
• Device Model Number: 6225I
• Device Catalogue Number: 6225I
• Device Lot Number: 0007400721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2014
• 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