MAUDE Adverse Event Report: GETINGE US SALES LLC / DATASCOPE CORP. MAQUET-GETINGE BALLOON PUMP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number SENSATION PLUS 8F 50ML

Device Problems Deflation Problem (1149); Material Rupture (1546)

Patient Problems Hemorrhage/Bleeding (1888); Vascular Dissection (3160)

Event Date 11/01/2020

Event Type  Injury  

Event Description

While pt was in the cvicu the pt turned in bed and blood was noted in the iabp (which was placed on (b)(6) 2020).The cath lab team was called in to remove the iabp under fluoroscopy.The interventional cardiologist was unable to remove the iabp end called vascular surgery.Vascular surgery took the patient to the or end did a cut down to remove the balloon.It was noted that the balloon was ruptured und did not deflate completely causing a tear in the femoral artery.The artery was patched successfully without complication.Plaque was noted in the artery.

• Brand Name: MAQUET-GETINGE BALLOON PUMP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): GETINGE US SALES LLC / DATASCOPE CORP.
• MDR Report Key: 10829328
• MDR Text Key: 216186599
• Report Number: MW5097803
• Device Sequence Number: 1
• Product Code: DSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: SENSATION PLUS 8F 50ML
• Device Catalogue Number: 0684-00-0576
• Device Lot Number: 300126212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 77