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

Model Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Abdominal Pain (1685)

Event Date 02/28/2022

Event Type  Injury  

Manufacturer Narrative

Type of investigation not yet determined (4118) additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.Not returned to manufacturer.

Event Description

It was reported that pumping was performed after the cathere was placed.Approximately one day of intra-aortic balloon pump (iabp) therapy the console generated a gas loss in iab circuit alarm and a check iab catheter alarm.The patient was stable, but complained of abdominal pain so the iab was removed.Upon removal, blood was found inside the iab.The customer suspects a helium embolism.The patient was later discharged.The associated intra-aortic balloon (iab) has been reported under medwatch 2248146-2022-00240.

Manufacturer Narrative

A getinge representative communicated that the issue (alarm) was caused by the broken inner lumen due to the kink of the iab catheter.There was no information received regarding the iabp unit.

Event Description

N/a.

• Brand Name: UNKNOWN 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: 13954317
• MDR Text Key: 289775055
• Report Number: 2249723-2022-00691
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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?: No
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TRANS-RAY PLUS 7.5 FR. 40CC IAB
• Patient Outcome(s): Other