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

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/27/2022

Event Type  Injury  

Event Description

It was reported that during intra-aortic balloon (iab) therapy blood was seen in the inner lumen line running to the flush bag.The customer proceeded to flush the line for a few minutes until it cleared.Directly after that, the patient developed some chest tightness and shortness of breath for a period of about 10 minutes.The customer wanted to know what it may mean clinically and if the iab may need to be removed from the patient.The getinge representative asked if the pump was put in standby, as per the ifu during flushing.The customer stated that they had not put the pump in standby.The getinge representative reviewed the importance of performing flushing while in standby and the possible clinical results if not followed correctly.The customer then stated that the patient seem clinically stable and therapy was being delivered as expected.The customer ordered a chest x-ray which indicated that the iab was not in the proper position.It was later reported that the patient was stable.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).

• Brand Name: UNKNOWN INTRA-AORTIC BALLOON
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 14112176
• MDR Text Key: 289270574
• Report Number: 2248146-2022-00300
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR