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

Model Number AB46

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/02/2020

Event Type  Death  

Manufacturer Narrative

Other relevant device(s) are: product id: ab46, serial/lot #: (b)(4), ubd: 22-apr-2022, udi#: (b)(4); product id: ab46, serial/lot #: (b)(4), ubd: 22-apr-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

3 reliant balloons were used in order to clamp and occlude the aorta in the endovascular treatment of an aneurysm.It was reported that all balloons showed leaks and did not achieve the required hemostasis which led to a serious deterioration in the patient's heath reportedly.As per the physician the cause of the event was that the balloons that were supposed to achieve hemostasis showed leaks.No additional clinical squeal were provided and the patient will be monitored.

Manufacturer Narrative

It was reported the patient had a non medtronic endoprosthesis previously implanted, due to neck dilation the physician decided to r emove the stent by cutting it just below the supra renal fixation and to suture on an aorto bi-iliac prosthesis.It was reported a reliant balloon was used to clamp the aorta instead of an aortic clamp due to the suprarenal stent fixation that remained in place.It was reported while attempting to use the balloon to stop the blood flow; 25 minutes after inflation the balloon showed a leak and a second balloon was then used to stop the blood flow.After 15 mins it was reported the second balloon also showed a leak.A third balloon was then used and again after 10 minutes the balloon showed a leak.It was reported at this time the patient had lost too much blood and expired.It was reported that prior to use the wire lumen was irrigated but not the balloon lumen.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis conclusion; on inflation two pin hole leaks were observed from the mid-section of balloon.The reported leak was confirmed through analysis.B:5 additional information received; it was noted that the blood pressure wasn't unusual, between 9-12 systolic.The balloon was never in contact with the suprarenal stents as it was always used above the coeliac trunk.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: RELIANT BALLOON
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 10958468
• MDR Text Key: 219879783
• Report Number: 9612164-2020-04789
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2022
• Device Model Number: AB46
• Device Catalogue Number: AB46
• Device Lot Number: 0010223396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Death; Other
• Patient Age: 76 YR