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

Model Number REL46J

Device Problems Leak/Splash (1354); Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A reliant balloon was intended to be used in an unknown endovascular procedure.It was reported that when the device was being prepped, the saline solution could not pass through the guidewire lumen.It was thought there was some unevenness/roughness or foreign material in the lumen, thus the flushing could not be performed.As per the physician the cause of the event can not be determined.No additional clinical sequalae were provided 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: 9961868
• MDR Text Key: 187951425
• Report Number: 9612164-2020-01568
• 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: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REL46J
• Device Catalogue Number: REL46J
• Device Lot Number: 0010116403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2020
• Initial Date FDA Received: 04/15/2020
• 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