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

Model Number UNKNOWN

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/04/2021

Event Type  Death  

Manufacturer Narrative

Device not accessible for testing: at this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.Not returned to manufacturer.

Event Description

It was reported that during insertion of an intra-aortic balloon in a patient with cardiac arrest post coronarography, the customer could not insert the guidewire through the iab and noted that the iab was broken after 12cm.A new iab was inserted without further issue.Therapy with an unknown intra-aortic balloon pump (iabp) was then provided.It was later reported that the patient had died.The customer does not attribute the patient's death to the iabp device and there was no reported malfunction of the iabp.This report is for the iabp used during the reported event.Separate reports have been submitted for the iab catheters in use.Reference report numbers: 2248146-2021-00699 and 2248146-2021-00698.

Manufacturer Narrative

Updated fields: b4, g3, g6, g7, h2, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: g1(contact person).Three (3) good faith efforts (gfes) to obtain the relevant repair and iabp status related to this complaint were made to the customer.However, despite our best efforts, customer has not responded to any of our gfes.Consequently, this complaint is being closed due to insufficient information.

Event Description

N/a.

• Brand Name: 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: 12720559
• MDR Text Key: 279054985
• Report Number: 2249723-2021-02502
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 10/29/2021
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SENSATION 34CC; SENSATION 34CC
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 100 KG