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

Model Number UNKNOWN

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

Patient Problems Death (1802); Toxemia (2207)

Event Date 10/05/2020

Event Type  Death  

Manufacturer Narrative

There was no reported malfunction of the unit and neither the pump model or serial number was provided. However, additional information is being requested, and we will submit a supplemental report, if necessary. Not returned to manufacturer.

Event Description

An aortic valve replacement associated with pericardial patch (re-operation) was performed. A datascope trans ray plus 35cc intra-aortic balloon (iab) catheter was used along with an unknown datascope intra-aortic balloon pump (iabp) to provide iabp counterpulsation therapy as well. The surgery was completed successfully and iabp therapy was continued after the surgery. 3 days later, the iabp therapy was discontinued and the iab catheter was removed safely from the patient. The iab catheter was discarded in the hospital. It was reported that after removal of the of the iab catheter, the patient condition deteriorated and a positive reaction was observed for endotoxin shock the following morning. This report is for the unknown datascope intra-aortic balloon pump reported to be used in this event. There was no reported malfunction of the datascope intra-aortic balloon pump. The iab catheter will be reported in a separate mdr.

• Brand Name: UNKNOWN DATASCOPE INTRA-AORTIC BALLOON PUMP
• 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: 10742361
• MDR Text Key: 213418935
• Report Number: 2249723-2020-01771
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/28/2020
• 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: 10/27/2020 Patient Sequence Number: 1