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

Model Number 6225I

Device Problem Deflation Problem (1149)

Patient Problem Vascular Dissection (3160)

Event Date 04/14/2015

Event Type  Injury  

Event Description

It was reported that during the implant procedure, the patient's coronary sinus was minorly dissected while utilizing the balloon ca theter.It was noted the balloon catheter was unable to deflate after performing the venogram, so the physician attempted to deflate the balloon by creating negative pressure with the syringe but the balloon would not deflate.The physician then pulled the inflated balloon with the coronary sinus catheter and the coronary sinus was minorly dissected.The balloon catheter was removed from the patient.No further patient complications have been reported as a result of this event.

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.(b)(4).

Manufacturer Narrative

The catheter was returned, analyzed and the mechanical operation of the catheter shaft was bent.It was noted the catheter shaft was kinked in various locations (damaged during procedure), the balloon could not inflate and blood (and what appeared to be contrast) was visible at various locations on the catheter.Visual summary analysis of the lead indicated damage at implant.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 4829849
• MDR Text Key: 5909654
• Report Number: 9612164-2015-00937
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K121219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2015
• Device Model Number: 6225I
• Device Catalogue Number: 6225I
• Device Lot Number: 0007239280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 06/10/2015
• Supplement Dates Manufacturer Received: Not provided; 06/08/2015
• Supplement Dates FDA Received: 08/04/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2014
• 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 Outcome(s): Life Threatening; Required Intervention
• Patient Age: 00076 YR