MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH UNKNOWN; 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 Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint.It was reported that there was no inference of a pump problem given by the customer.The balloon was placed in an off-label method; therefore, the fiber-optic mechanism did not work correctly.The user made an error when attempting to aspirate the fluid lumen of the balloon and allowed air to enter the system.This led to a long period of balloon immobility,as they worked to remedy the situation.The customer affirmed that there is no way they can identify the pump used in the event and the balloon has been discarded.Since there was no reported malfunction of the iabp, no further evaluation is required.If additional information is provided, a supplemental report will be submitted accordingly.

Event Description

It was reported that during therapy using an unspecified intra-aortic balloon pump (iabp) and a unknown iab catheter via axillary approach (off-label use), the iabp unit displayed a sensor failure alarm.It was further reported that when switching to use the fluid lumen, the nurse could not aspirate the lumen clean and got air into the flush tubing.The nurse then had to clamp the tubing.When the balloon was being removed, a large clot reportedly dislodged and caused the patient to lose pulse in one arm.The clot was surgically removed and there was no lasting effect for the patient.The customer did not provide the model name or serial number of the iabp in use during this event.In addition, there was no reported malfunction of the involved iabp.The iab used during this event was reported under mfg report number 2248146-2019-00700.

• 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: 8925954
• MDR Text Key: 155500923
• Report Number: 2249723-2019-01349
• 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
• Type of Report: Initial
• Report Date: 08/23/2019

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: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/23/2019
• 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): Other; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 82