MAUDE Adverse Event Report: MEDTRONIC, INC. ATTAIN VENOGRAM BALLOON CATHETER; CATHETER, FLOW DIRECTED

Model Number 6215

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 01/19/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the balloon catheter was returned and analyzed.No anomalies were found.The analyst noted a test guidewire was fully inserted into the balloon catheter.

Event Description

It was reported that during the implant procedure, the balloon catheter was inserted into the coronary sinus and as the physician attempted to insert a guidewire into the balloon catheter, it was not possible to enter the lumen of the balloon catheter more than a few centimeters.The balloon catheter was replaced.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN VENOGRAM BALLOON CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6470395
• MDR Text Key: 72202741
• Report Number: 2182208-2017-00647
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00613994842114
• UDI-Public: 00613994842114
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K012225
• 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: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2018
• Device Model Number: 6215
• Device Catalogue Number: 6215
• Device Lot Number: 0061504143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1