MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH PRODUCT NOT IN LIST - IABP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number PRODUCT NOT IN LIST - IABP

Device Problems Failure to Sense (1559); Pressure Problem (3012)

Patient Problem Cardiac Tamponade (2226)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

Additional information is being requested from the customer with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.Device not accessible for testing.

Event Description

It was reported during use that the insert the catheter and input the blood pressure signal to the iabp device via optical fiber.Central lumen is primed with heparinized saline.The patient's condition becomes cardiac tamponade and thoracotomy is performed.At that time, the blood pressure signal input by the optical fiber was dull, so the hospital staff tried to obtain the blood pressure signal from the central lumen with a transducer, but the central lumen was clogged and i gave up obtaining the blood pressure signal from the central lumen.Therefore, the catheter was replaced with a new trp4046.The replaced trp4046 was able to be driven by inputting signals without any problems.When i checked the tip of the catheter of the product that was the target of the defect, there was a request to investigate the cause of what seems to be a piece of tissue attached, whether this was the lead of the optical fiber signal.Please refer to related mfg report number 2248146-2021-00536 on the involved intra-aortic balloon (iab).

Event Description

N/a.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and the customer has told the fse that the iabp equipment has not broken down, so the fse have not performed any maintenance work.The fse reported there was no failure of the iabp.Good faith efforts (gfe) attempts were made to the customer to obtain additional information on this complaint event.No response has been received, therefore this complaint is being closed.If information is received, we will reopen and update the complaint.

• Brand Name: PRODUCT NOT IN LIST - 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: 12362598
• MDR Text Key: 267971172
• Report Number: 2249723-2021-01896
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PRODUCT NOT IN LIST - IABP
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: IAB; IAB
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose