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

Model Number	REL46
Medical Device Problem Codes	Break (1069); Inability to Irrigate (1337)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 for a 5mm aneurysm.It was reported that during the index procedure, a syringe was attached to the plastic distal part of the flush port in order to flush saline through the device.When the surgeon went to advance the saline it sprayed out the side of the plastic and the physician said it looked like it was cracked.As per the physician the cause of the event is due to the a crack in the flush port of the reliant balloon.It was noted that the event was resolved with the use of another reliant balloon on the same day.No additional clinical sequelae were reported and the patient is fine.Medical history; (b)(6).
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7349116
• Report Number: 2953200-2018-00386
• Device Sequence Number: 723482
• Product Code: DQY
• UDI-Device Identifier: 00643169707641
• UDI-Public: 00643169707641
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/03/2018

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: 11/15/2019
• Device Model Number: REL46
• Device Catalogue Number: REL46
• Device Lot Number: 0008882103
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 06/27/2018; 08/08/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 08/08/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1