MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0576-01

Device Problem Optical Problem (3001)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2022

Event Type  Death  

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).Device not returned.

Event Description

It was reported that shortly after inserting the intra-aortic balloon (iab), the console generated a fiber optic sensor failure message.The customer was able to connect and successfully transduce the central lumen for an arterial line prior to our call back.They were advised in possible causes for the message such as damage to the sensor, or wetness at the connection during setup.At that time, the patient was stable and being transferred to the icu.There was no patient harm or adverse event reported.

Manufacturer Narrative

Additional updated information: complete initial reporter name - (b)(6).Adverse event or product problem, outcome attributed to ae, describe event or problem , device available for eval?, initial reporter, type of reportable event, health effect ¿ clinical code, health effect ¿ impact codes.The device was not returned and could not be evaluated.It was not saved by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id # (b)(4).

Event Description

It was reported that shortly after inserting the intra-aortic balloon (iab), the console generated a fiber optic sensor failure message.The customer was able to connect and successfully transduce the central lumen for an arterial line prior to our call back.They were advised in possible causes for the message such as damage to the sensor, or wetness at the connection during setup.At that time, the patient was stable and being transferred to the icu.It was later reported that the patient did not survive and iab was not saved.

Manufacturer Narrative

Updated fields - event site email, describe event or problem.Complaint record id # (b)(4).

Event Description

It was reported that immediately after inserting the intra-aortic balloon (iab), the console generated a fiber optic sensor failure message.The fiber optic did not work from the onset of plugging it in.Therapy was started by unplugging the fiber optics and were using ecg trigger.The customer was able to connect and successfully transduce the central lumen for an arterial line prior to our call back.They were advised in possible causes for the message such as damage to the sensor, or wetness at the connection during setup.At that time, the patient was stable and being transferred to the icu.It was later reported that the patient did not survive and iab was not saved.

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 PLUS 8FR. 50CC 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: 15920414
• MDR Text Key: 306978060
• Report Number: 2248146-2022-00940
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112327
• 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,Followup,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2024
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000143119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 95 KG