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

Catalog Number 0684-00-0475

Device Problems Leak/Splash (1354); Pressure Problem (3012)

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

Event Date 03/02/2024

Event Type  malfunction  

Event Description

It was reported that during intra-aortic balloon (iab) therapy, there was a lack of pressure reading and a "no source" message was noted.Once it was verified that it was not a problem concerning the connecting cable, an initial counter-pulsation maneuver was attempted.However, the curve was abnormal and blood was detected in the iab.The iab was replaced and therapy was provided.There was no patient harm or adverse event reported.

Manufacturer Narrative

Initial reporter: (b)(6).Event site name: (b)(6).Event site postal code: (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).

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint (b)(4).

Event Description

N/a.

• Brand Name: LINEAR 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: 18981906
• MDR Text Key: 338635505
• Report Number: 2248146-2024-00177
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106571
• UDI-Public: 10607567106571
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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: 3000332648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.