MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH UNKNOWN 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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/30/2021

Event Type  Injury  

Manufacturer Narrative

Device not accessible for testing: device is not accessible for testing due to the customer not requesting repair.

Event Description

It was reported that during insertion of an intra-aortic balloon (iab) catheter, the sheath could not be inserted.The iab catheter and sheath were both replaced.However, as there was difficulty inserting the first sheath, the existing incision needed to be made larger in order to insert the second sheath.This was successful and therapy was continued with the second iab and sheath.This report is for the intra-aortic balloon pump (iabp) that was in use during this event.There was no reported malfunction of the iabp.Both iab catheters used in this event are reported on separate mdrs.

Event Description

N/a.

Manufacturer Narrative

There was no reported malfunction of the iabp.A getinge field service engineer (fse) was not dispatched to evaluate the iabp unit because the issue was that the sheath was unable to insert into the patient prior to connecting iab catheter to iabp unit and any malfunction shouldn¿t occur on iabp unit.If additional information on the product and serial# is received, we will reopen and update the complaint.

• Brand Name: UNKNOWN INTRA-AORTIC BALLOON PUMP
• 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: 12088414
• MDR Text Key: 264118758
• Report Number: 2249723-2021-01363
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/15/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER.
• Patient Outcome(s): Required Intervention