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

Model Number	REL46
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The main component of the system.Other relevant devices are: rel46 ; s/n: (b)(4); use by date: (b)(6) 20179 ; upn # (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A reliant balloon was used in the endovascular treatment of the patient.It was reported that during the index procedure when ballooning the distal aorta, the proximal stent graft and the stent graft overlap sections were ballooned with no issue.It is noted that a kissing technique was performed in the distal aorta and that the balloons where moved to the iliac limbs (16x10x124) and inflated at the same time.Both balloons burst at the same time in the proximal common iliac arteries.The event was resolved with the replacement of the balloons and the procedure was completed.As per the physician the cause of the event is device related.No additional clinical sequelae were reported, and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary; the exact cause of the bilateral balloon burst occurring using kissing ballooning technique within the common iliac arteries could not be determined from the pre-implant films provided.Films during implant were not available for review, and the reported balloon burst event could not be assessed.Post-implant films were also not available.This may have been procedure related caused by over-inflation, possibly in combination with implanting within the calcified distal aorta and bilaterally calcified common iliac arteries.This may have also been related to an issue with the balloons.The balloons have been returned and are awaiting analysis, and the findings will be summarized in a separate report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: there was blood residue visible in the balloon indicating the presence of a leak.Negative prep was performed and detected a leak.On pressurization of the device a leak was detected from the distal cone of the balloon.Visual inspection confirmed the presence of a long radial tear on the distal cone.The balloon material was jagged and uneven at the leak site.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RELIANT BALLOON
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7282145
• Report Number: 2953200-2018-00259
• Device Sequence Number: 143604
• Product Code: DQY
• UDI-Device Identifier: 00643169707641
• UDI-Public: 00643169707641
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K050038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2019
• Device Model Number: REL46
• Device Catalogue Number: REL46
• Device Lot Number: 0008873850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 03/02/2018; 06/19/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/27/2018; 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR