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

Catalog Number 0684-00-0293

Device Problem Leak/Splash (1354)

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

Event Date 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: (b)(6).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.Reference complaint #(b)(4).

Event Description

It was reported that after approximately six days of intra-aortic balloon (iab) therapy, the intra-aortic balloon pump (iabp) alarmed a "high pressure/kink" on (b)(6) 2024.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The iab fill volume deflated to 35ml and remained there until a rupture occurred.On (b)(6) 2024 at 1343, the iabp generated a a "high pressure/kink" alarm and blood was found in the helium line.The line was clamped and the iab was removed at 1401.There was no patient harm or adverse event reported.

Manufacturer Narrative

Updated field(s): describe event or problem the device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).

Event Description

It was reported that after approximately six days of intra-aortic balloon (iab) therapy, the intra-aortic balloon pump (iabp) alarmed a "high pressure/kink" on (b)(6) 2024.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The iab fill volume deflated to 35ml and remained there until a rupture occurred.On (b)(6) 2024 at 1343, the iabp generated a a "high pressure/kink" alarm and blood was found in the helium line.The line was clamped and the iab was removed at 1401.A new iab was inserted later that day and therapy was continued.There was no patient harm or adverse event reported.

• Brand Name: MEGA 7.5FR. 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: 19014584
• MDR Text Key: 339051716
• Report Number: 2248146-2024-00186
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107981
• UDI-Public: 10607567107981
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000308473
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 49 KG