MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0998-00-3023-XX

Device Problems Bent (1059); Kinked (1339); Difficult to Remove (1528)

Patient Problems Calcium Deposits/Calcification (1758); Death (1802); Rupture (2208); Cardiac Tamponade (2226)

Event Date 12/16/2017

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.The business unit confirmed that there was no alleged malfunction of the iabp involved in this event.Therefore, no evaluation was needed.This report has been sent per company protocol of co-reporting when the event description entails a serious injury or death regarding the iabp/ iab.The customer confirmed that there was no malfunction with the iabp.There was no further information provided.

Event Description

It was reported that cs300 intra aortic balloon pump therapy started on an acute myocardial infarction (ami) patient using the ymt30r-01 catheter.The sheath was difficult to advance.While attempts were made to insert the guide wire it bent and the sheath was being kinked.They were unable to remove the iab and bleeding didn¿t stop so an incision was made to remove the iab.The patient expired the next day by cardiac tamponade due to myocardial rupture.Mild tortuosity, sclerosis and calcification were noted in the patient vessel.There was no alleged malfunction of the cs300.The death is not attributed to the cs300.Related balloon emdr (b)(4).

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 7183152
• MDR Text Key: 97048015
• Report Number: 2249723-2018-00051
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063525
• 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: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-3023-XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 12/21/2017
• Date Device Manufactured: 05/30/2008
• 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
• Patient Outcome(s): Death
• Patient Age: 83 YR