MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT STENT GRAFT BALLOON CATHETER -OUS; CATHETER, PERCUTANEOUS

Model Number REL46J

Device Problems Inability to Irrigate (1337); Component or Accessory Incompatibility (2897)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned for analysis.The events were confirmed; there was difficult passing a guidewire and difficulty flushing the reliant balloon.The root cause of the event was most likely related to the physician¿s decision to cut the guidewire after part of it had become contaminated during the procedure and then trying to re-insert the cut end back through the guidewire lumen.The cut end of the guidewire then scraped along the inner lumen causing the material to build up as the guidewire was passed and ultimately led to the occlusion at the distal tip.

Event Description

A reliant balloon catheter was selected as an accessory device for the treatment of an abdominal aortic aneurysm.It was reported that the during the procedure, after the guidewire was inserted through the reliant balloon without issue, the guidewire had become dirty.The physician removed the guidewire and cut off a part of the contaminated wire.The physician then tried to insert the cut end of the guidewire back through the reliant balloon; however, had difficulty in insertion into guide wire lumen.The physician then attempted to flush the lumen however, was unsuccessful.No clinical sequelae were reported.

• Brand Name: RELIANT STENT GRAFT BALLOON CATHETER -OUS
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 5310848
• MDR Text Key: 34612210
• Report Number: 2953200-2015-02385
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050038
• 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: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2017
• Device Model Number: REL46J
• Device Catalogue Number: REL46J
• Device Lot Number: 0007731195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• 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