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 Thrombus (2101)

Event Date 11/16/2019

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information from the journal article entitled: a retrospective analysis of the treatment on abdominal aortic balloon occlusion-related thrombosis by continuous low-flow diluted heparin rongguang luo, fen wang, yanxing guan, junhui wan, wentao zhang and zhifeng duan medicine 2019 volume 98 issue 51 http://dx.Doi.Org/10.1097/md.0000000000018446.If information is provided in the future, a supplemental report will be issued.

Event Description

Reliant balloons were used for the prophylactic balloon occlusion of the abdominal aorta for women with pernicious placenta previa to prevent massive bleeding during caesarean section.Six women developed thrombosis in the right lower extremity post operatively, with no lower limb ischemia reported.The thrombus of 5 women was successfully treated and one was lost to follow up.The causes of thrombosis were not completely defined but the technical skill and length of time the balloon catheter remained in the body were possible factors.

• 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: 9804920
• MDR Text Key: 189308738
• Report Number: 9612164-2020-01069
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/09/2020

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: 02/21/2020
• Initial Date FDA Received: 03/09/2020
• 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): Required Intervention
• Patient Age: 32 YR