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

Model Number N/A

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

Patient Problem Injury (2348)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

A company representative has advised that the customer has not alleged a malfunction of the iabp, and the pump model and serial number have not been provided. If additional information is provided, a supplemental report will be submitted.

Event Description

It was reported that while in use, blood was barely seen in the gas line of a datascope manufactured intra-aortic balloon pump (iabp). The iabp type is unknown. The iabp was then placed in stand-by mode 1. 5 hours prior to the intra-aortic balloon catheter (iabc) removal because the patient was heparinized. When the cardiologist attempted removal of the iabc, it was found to be entrapped, so it was necessary to remove it surgically. There was no reported malfunction of the iabp by the customer. The intra-aortic balloon catheter has been submitted under a separate manufacturer¿s report, reference report 2248146-2020-00517.

• Brand Name: UNKNOWN IABP
• 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: dorota wolpiuk ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 10616747
• MDR Text Key: 209572211
• Report Number: 2249723-2020-01598
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/30/2020
• 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 Treatment Data

Date Received: 10/01/2020 Patient Sequence Number: 1