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	07/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A reliant balloon was used in a patient to model an endurant [16x13x199] stent graft limb.A 20cc syringe filled with a 70% saline and 30% contrast was used to inflate the balloon with moderately applied pressure.Ballooning began post stent graft placement at the proximal end of the stent graft.On approximately the third overlapping inflation, moving distal within the limb, the balloon ruptured with approximately 5cc of injection.The stent graft remained in place.A new balloon was used and the event was resolved.The physician stated that the cause of the event could not be determined.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: RELIANT BALLOON
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6803129
• Report Number: 2953200-2017-01317
• Device Sequence Number: 13723172
• 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
• Report Date (Section B): 07/28/2017

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: 04/21/2019
• Device Model Number: REL46
• Device Catalogue Number: REL46
• Device Lot Number: 0008595442
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR