MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH UNKNOWN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

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

Patient Problem Death (1802)

Event Date 01/30/2021

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per sop since the serial number for the unit was not provided.At this time, the customer has not requested getinge to evaluate the iabp.The getinge field service engineer reported that the iabp did not malfunction.

Event Description

The intra-aortic balloon catheter was inserted for a patient post cabg (3x) and after the guide catheter was moved past the iab, the md and rn noticed that the iab was not in the right place and was bent over.Customer could not pass a wire through to replace the balloon and had to replace the iab.Once the iab was replaced, everything worked.Patient did pass away a few days after procedure.This report is for the intra-aortic balloon pump (iabp) used in the reported event.The facility is unable to identify the iabp used in the event, since there was no reported malfunction and they are moved around frequently.Balloon complaint created.

• Brand Name: UNKNOWN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 11375279
• MDR Text Key: 233434548
• Report Number: 2249723-2021-00384
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER SENSATION PLUS 40CC.
• Patient Outcome(s): Death
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 120 KG