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

Catalog Number 0998-00-0800-31

Device Problems Entrapment of Device (1212); Retraction Problem (1536); Physical Resistance (2578); Device Displays Incorrect Message (2591)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/22/2017

Event Type  Injury  

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 company representative evaluated the unit and reported that this event was caused by a hole in the catheter and the intra aortic balloon pump (iabp) performed as expected in this situation.

Event Description

The intra aortic balloon (iab) was inserted into the patient in the cardiac intensive care unit (icu) post mitral valve replacement (mvr), aortic valve replacement (avr) and coronary artery bypass graft (cabg) for low cardiac output and patient deterioration.This was conducted by the surgeon without image intensifier.The cardiosave later alarmed "gass loss in iab circuit".The extra corporeal tubing was assessed and blood was noted.This occurred 12 hours after the iab was inserted.The cardiosave was stopped in order to attempt to remove the iab, resistance was found so the patient was taken to the operating room (or) for removal of the iab.A new iab was inserted under image intensifier in vascular or.Related balloon medwatch 2248146-2017-00314.

• Brand Name: CARDIOSAVE
• 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: 6816696
• MDR Text Key: 83492033
• Report Number: 2249723-2017-00330
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-0800-31
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2012
• 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): Required Intervention
• Patient Age: 70 YR