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

Model Number 6215

Device Problem Mechanical Problem (1384)

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

Event Date 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the balloon catheter was returned and analyzed.The mechanical operation of the balloon catheter was occluded.Visual summary analysis of the catheter indicated damage during use.The analyst noted a test sample guidewire was inserted but stopped at 19.5 cm due to crystallized saline.Once the lumen was flushed with alcohol, the guidewire was fully inserted with no anomaly.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant procedure, the physician could not get the wire through the tip of the balloon catheter.The catheter was used for the 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8805911
• MDR Text Key: 151558299
• Report Number: 2182208-2019-01307
• 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: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2020
• Device Model Number: 6215
• Device Catalogue Number: 6215
• Device Lot Number: 0061628442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2018
• 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: 65 YR