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

Model Number REL46J

Device Problems Burst Container or Vessel (1074); Material Rupture (1546); Defective Component (2292)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A reliant balloon was being used as an accessory device for an unknown endovascular treatment.During the index procedure it was reported, while the balloon was inside the stent graft it ruptured while being inflated for the second time.The device was replaced by another manufacturers balloon to complete the procedure.As per the physician, the cause of the event was due to a defective product.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

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

• 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 IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7746248
• MDR Text Key: 116098378
• Report Number: 2953200-2018-01130
• Device Sequence Number: 0
• Product Code: DQY
• 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,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2020
• Device Model Number: REL46J
• Device Catalogue Number: REL46J
• Device Lot Number: 0009092152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• 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