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

Model Number N/A

Device Problem Failure to Advance (2524)

Patient Problem Death (1802)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided.There was no reported malfunction of the iabp and the company representative who assisted the customer has confirmed that the issue solely balloon related and there was no issue with the iabp.No further investigation is required.

Event Description

It was reported that during intra aortic balloon pump (iabp) therapy, the customer emergently tried to insert a sensation plus 40cc intra-aortic balloon catheter (iabc) on the or table and it would not advance through the sheath.It was reported that the patient subsequently expired; however, the customer stated that the patient did not die due to lack of the iabc not inserted.There was no reported malfunction of the intra-aortic balloon pump (iabp), and the customer does not attribute the patient's death to the iabc or iabp.The date of the patient's death is unknown.The report for the involved intra aortic balloon has been submitted under mfg reporter # 2248146-2019-00296.

• Brand Name: UNKNOWN
• 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: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 8533660
• MDR Text Key: 142773510
• Report Number: 2249723-2019-00640
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Device Age: YR
• Date Manufacturer Received: 03/27/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Death