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

Model Number PRODUCT NOT IN LIST - BALLOON CATHETER

Device Problem Optical Problem (3001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/20/2022

Event Type  Death  

Event Description

It was reported that while attempting to initiate intra-aortic balloon (iab) therapy, the cardiosave intra-aortic balloon pump (iabp) generated a fiber optic sensor failure alarm.Both the iab and iabp were replaced.The same issue had occurred so the iabp was switched out with a third one.The patient later expired.This report is for the second iab used in this event.A separate report has been submitted for the first iab under mfg report number 2248146-2022-00538.

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).

Manufacturer Narrative

The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted complaint record id #(b)(4).

Event Description

N/a.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.A sensor output test was performed and the sensor was found to be within specification.The reported event cannot be confirmed by the evaluation.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint # (b)(4).

Event Description

N/a.

• 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: 14988145
• MDR Text Key: 295709278
• Report Number: 2248146-2022-00539
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: PRODUCT NOT IN LIST - BALLOON CATHETER
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000121471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 09/01/2022; 10/21/2022
• Supplement Dates FDA Received: 09/06/2022; 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE - CH222581K5, CH325106H0, CH222871K5.
• Patient Outcome(s): Death
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 90 KG