MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0469-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/26/2020

Event Type  Death  

Manufacturer Narrative

(b)(6).The device was not returned and could not be evaluated.It was discarded 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).Device not returned.

Event Description

It was reported that during startup of the intra-aortic balloon(iab) therapy, the console generated a fiber optic sensor failure alarm.Despite several attempts to try to resolve the problem, the counterpulsion therapy could not be started.Decision to change the iab.The new iab works immediately but the time lost in changing the balloon does not save the patient who goes into cardiac arrest and dies despite the resuscitation measures implemented.This report is for the 2nd iab.A separate report is submitted for the 1st iab.

Event Description

It was reported that during startup of the intra-aortic balloon(iab) therapy, the console generated a fiber optic sensor failure alarm.Despite several attempts to try to resolve the problem, the counterpulsion therapy could not be started.Decision to change the iab.The new iab works immediately but the time lost in changing the balloon does not save the patient who goes into cardiac arrest and dies despite the resuscitation measures implemented.This report is for the 2nd iab.A separate report is submitted for the 1st iab.

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.There was no reported malfunction.All the failure modes are addressed in the risk file.No labeling review can be completed as there was no reported malfunction.There were no crf/capa/scar/nmcr identified for "no reported malfunction".The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint# (b)(4).

• Brand Name: SENSATION 7FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 11041465
• MDR Text Key: 222514604
• Report Number: 2248146-2020-00677
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106755
• UDI-Public: 10607567106755
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/31/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2022
• Device Model Number: 0684-00-0469-01
• Device Catalogue Number: 0684-00-0433
• Device Lot Number: 3000110392
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 12/31/2020
• Supplement Dates FDA Received: 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE; CARDIOSAVE
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Weight: 75