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

Model Number 6215

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Manufacturer Narrative

Medtronic was made aware of this event through a physician survey.It was not possible to ascertain specific device information outside of model number or to match the event with previously reported events.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Of note, multiple patients were noted in the survey; however, a one to one correlation could not be made with unique product lot numbers.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the procedure that utilized a balloon catheter, there were issues with insertion and withdrawal.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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9433418
• MDR Text Key: 170314248
• Report Number: 2182208-2019-02219
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6215
• Device Catalogue Number: 6215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2019
• 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