MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0475

Device Problems Difficult to Advance (2920); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2023

Event Type  malfunction  

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).H3 other text : device not returned.

Event Description

It was reported that the intra-aortic balloon (iab) had been inserted on (b)(6) 2023.The insertion was reported to be axillary, which is not the method described in the device instructions for use.On (b)(6) 2023, the iab was attempted to be repositioned but advancement with catheter cover was difficult and met with resistance.A second iab was inserted via left axillary.On (b)(6) 2023, autofill failure and a leak in iab circuit alarms occurred.A third iab was inserted via left axillary.On (b)(6) 2024, an autofill failure alarm occurred on the third iab.A fourth iab was inserted via left axillary.There were no ruptures, no blood in drive line, and no issue with the console during any of the iab replacements.There was no patient harm or adverse event reported.This report is for the 1st iab involved in this event.Separate reports will be submitted for the 2nd and 3rd iabs.

Event Description

It was reported that the intra-aortic balloon (iab) had been inserted on (b)(6) 2023.The insertion was reported to be axillary, which is not the method described in the device instructions for use.On (b)(6) 2023, the iab was attempted to be repositioned but advancement with catheter cover was difficult and met with resistance.A second iab was inserted via left axillary.On (b)(6) 2023, autofill failure and a leak in iab circuit alarms occurred.A third iab was inserted via left axillary.On (b)(6) 2024, an autofill failure alarm occurred on the third iab.A fourth iab was inserted via left axillary.There were no ruptures, no blood in drive line, and no issue with the console during any of the iab replacements.There was no patient harm or adverse event reported.This report is for the 1st iab involved in this event.A separate report was submitted for the 2nd iab under mfg report number 2248146-2024-00070.Another separate report was submitted for the 3rd iab under mfg report number 2248146-2024-00071.

Manufacturer Narrative

Updated field: medical device ¿ problem code (2): removal of code "4003".The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).

• Brand Name: LINEAR 7.5 FR. 40CC IAB
• 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: 18642741
• MDR Text Key: 335939546
• Report Number: 2248146-2024-00067
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CS300
• Patient Sex: Male
• Patient Weight: 79 KG