MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT BALLOON; CATHETER, PERCUTANEOUS

Model Number AB46

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rupture (2208)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the reliant device.The exact size of the device is unknown.Survey results from an interventional cardiologist in practice 13 years, who has used the reliant device for expansion of vascular prostheses 60 times in total of which 50 of those times were in the last 12 months.For the temporary occlusion of large vessels it was used 10 times in total of which 8 of those times were in the last 12 months.During use of the reliant for expansion of vascular prostheses (assisting in the expansion of self-expanding stent grafts), the following complications were encountered; aneurysm rupture.During use of the reliant balloon for temporary occlusion of large vessels, the physician did not encounter any complications.Of the above complications reported, some of these are listed as having been reported to medtronic previously.Due to limited information these are included in reporting.No further information has or will be provided.

• Brand Name: RELIANT BALLOON
• 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: 10117973
• MDR Text Key: 193950325
• Report Number: 9612164-2020-02094
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• 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: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AB46
• Device Catalogue Number: AB46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/04/2020
• 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
• Patient Outcome(s): Other