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

Model Number 6215

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310)

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

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the during the implant attempt of the left ventricular (lv) lead, a balloon catheter was used to visualize the coronary veins.Four balloon inflations were done.On the fifth attempt to inflate the balloon, it would not inflate under fluoroscopy.The catheter was removed from the patient and the balloon still could not be inflated.A rupture of the balloon was suspected.The catheter was replaced with a new one to complete the procedure.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: the balloon catheter was returned and analyzed.The analysis indicated that the balloon was ruptured.The mechanical operation of the balloon catheter had leaks and/or was incontinent.Visual analysis of the balloon catheter indicated damage during use.The analyst noted the balloon catheter was returned without the inflation syringe.There was contrast on the infusion port and there was blood on the balloon at the distal end of the balloon catheter.There was blood and contrast at the distal orifice and a hole in the balloon at 0.5 cm from the distal end of the balloon catheter.The balloon would not stay inflated with air injected into the balloon.If information is provided in the future, a supplemental report will be issued.

• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9172867
• MDR Text Key: 161919596
• Report Number: 9612164-2019-04282
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123153
• 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,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2021
• Device Model Number: 6215
• Device Catalogue Number: 6215
• Device Lot Number: 0061660449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2019
• 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: 72 YR