MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0470-01

Device Problems Inability to Auto-Fill (1044); Calibration Problem (2890); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 12/23/2022

Event Type  Death  

Event Description

It was reported that after approximately 10 days of intra-aortic balloon (iab) therapy, the patient began presenting persistent infectious deterioration.Device-associated infection was suspected according to pet-scan imaging findings.The iab was removed and replaced with new one to continue therapy.Control of infectious condition in intensive care.

Manufacturer Narrative

Complete initial reporter name - (b)(6).Complete event site name - (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.Complaint record id # (b)(4).

Manufacturer Narrative

Updated field(s): outcome attributed to ae, date of death, describe event or problem, other relevant history , device available for eval? type of reportable event, type of investigation , health effect ¿ impact codes.Complaint record id # (b)(4).

Event Description

It was reported the intra-aortic balloon (iab) was inserted post-diagnosis coronary angiography.After approximately 10 days of therapy, the patient began presenting systemic inflammatory response and persistent infectious deterioration.It was noted that the console had generated unable to calibrate optical sensor and autofill failure alarms.Device-associated infection was suspected according to pet-scan imaging findings.Eight days later, the iab was removed and replaced with new one to continue therapy.Control of infectious condition in intensive care.It was later reported that the patient passed away on (b)(6) 2022.

Event Description

It was reported that after approximately two days of intra-aortic balloon (iab) therapy, the patient began presenting systemic inflammatory response and persistent infectious deterioration.It was noted that the console had generated unable to calibrate optical sensor and autofill failure alarms.Device-associated infection was suspected according to pet-scan imaging findings.Eight days later, the iab was removed and replaced with new one to continue therapy.Control of infectious condition in intensive care.

Manufacturer Narrative

Complaint record id # (b)(4).

Manufacturer Narrative

Updated field(s): describe event or problem.Complaint record id # (b)(4).

Event Description

It was reported the intra-aortic balloon (iab) was inserted post-diagnosis coronary angiography.After approximately 10 days of therapy, the patient began presenting systemic inflammatory response and persistent infectious deterioration.It was noted that the console had generated unable to calibrate optical sensor and autofill failure alarms.Device-associated infection was suspected according to pet-scan imaging findings.Eight days later, the iab was removed and replaced with new one to continue therapy.Control of infectious condition in intensive care.It was later reported that the patient passed away on (b)(6), 2022.Additional information received 27march2023.A 56-year-old male patient with a history of overweight and type 2 diabetes mellitus(dm) without medical management, who was admitted referred in the context of chest pain with a diagnosis of advanced lower wall ami and post-infarction angina, associated with moderate functional mitral regurgitation, and severely compromised systolic function with cardiomyopathy of ischemic etiology (lvef 25%) led to coronary angiography ((b)(6) 2022) in which severe multivessel disease with compromise of the heart was reported.Main trunk with thrombotic compromise with indication of surgical management.Iabp was advanced ((b)(6), 2022).Pet/ct was performed as an active search study for an infectious focus where there was uptake at the level of the iabp and the gallbladder.The balloon was removed.The adverse event is not associated with the device in use.

Event Description

N/a.

Manufacturer Narrative

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

• Brand Name: SENSATION 7FR. 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: 16197533
• MDR Text Key: 307621359
• Report Number: 2248146-2023-00039
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: 10607567106779
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K063525
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000239430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Required Intervention; Death
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 83 KG