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

Model Number 6215

Device Problems Material Fragmentation (1261); Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during the implant procedure and after the physician closed the incision of the pocket, two long threads of debris were pulled from the operative field.It was suspected, but unconfirmed, that these were part of the sheaths used during the implant procedure.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: 6007906
• MDR Text Key: 57109692
• Report Number: 2182208-2016-02392
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2016
• Device Model Number: 6215
• Device Catalogue Number: 6215
• Device Lot Number: 61390991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2016
• Date Device Manufactured: 09/22/2014
• 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