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

Model Number 0684-00-0576-01

Device Problem Restricted Flow rate (1248)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

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 intra-aortic balloon (iab) therapy, the console generated an iab catheter restriction alarm as the iab began to autofill.The iab tried to fill again, but the same alarm was generated.The iab was removed and replaced with a new one, but the same alarm occurred again.The customer then swapped out the console and the iab worked normally.Therapy was completed the following day.This report is for the 1st iab used in this event.A separate report will be submitted for the 2nd iab used.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.We are unable to confirm the reported event.If additional information is provided we will send a supplemental report with our additional findings.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.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).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the console generated an iab catheter restriction alarm as the iab began to autofill.The iab tried to fill again, but the same alarm was generated.The iab was removed and replaced with a new one, but the same alarm occurred again.The customer then swapped out the console and the iab worked normally.Therapy was completed the following day.This report is for the 1st iab used in this event.A separate report will be submitted for the 2nd iab used.

• Brand Name: SENSATION PLUS 8FR. 50CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10655212
• MDR Text Key: 210621169
• Report Number: 2248146-2020-00531
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1