MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH PRODUCT NOT IN LIST - IABP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number PRODUCT NOT IN LIST - IABP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

The getinge field service engineer reported that there was no malfunction of the iabp.

Event Description

It was reported that during intra-aortic balloon (iab) therapy the customer had seen blood inside the helium tubing.The patient was stable.The customer was advised to disconnect the iab from the console and remove the iab from the patient.Upon follow up approximately 40 minutes later.The iab still had not been removed.The console was in standby.The customer was advised to disconnect the helium tubing and power down the console.Cardiac surgeon was asked to assist removing required cut down and removal with "significant resistance".Pathology reports material in the iabp was desiccated thrombus.There was no malfunction of the iabp (intra-aortic balloon pump).Iab complaint reported under mfg report# 2248146-2021-00283.

Event Description

N/a.

• Brand Name: PRODUCT NOT IN LIST - IABP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 11904336
• MDR Text Key: 265001924
• Report Number: 2249723-2021-01139
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PRODUCT NOT IN LIST - IABP
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER- SENSATION PLUS
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 79 KG