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

Model Number REL46J

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A reliant stent graft balloon was attempted to be used in an unknown endovascular procedure.It was reported that during the index procedure, balloon breakage occurred during the initial ballooning.Alternatively, a non-medtronic balloon was used to complete the procedure.As per the physician, cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: RELIANT STENT GRAFT BALLOON CATHETER -OUS
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; IE ; 091708096
• MDR Report Key: 10493201
• MDR Text Key: 205976428
• Report Number: 9612164-2020-03338
• 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: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2021
• Device Model Number: REL46J
• Device Catalogue Number: REL46J
• Device Lot Number: 0009527019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2020
• Date Device Manufactured: 01/08/2019
• 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
• Patient Age: 77 YR