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 Problems Filling Problem (1233); Gas/Air Leak (2946); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2020

Event Type  malfunction  

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.Reference complaint # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the rn called from the cicu with a patient awaiting a return to the cardiac cath lab for a possible balloon leak.She reports being able to hear air movement leaking from the iab ¿sleeve¿ on the outside tubing.There is no report of observable blood early in the call.By the end of the call she wasn¿t sure if she could see discoloration in the helium tubing.It¿s not certain that she was looking at the correct tubing after discussion.The pump alarmed at various times during the call with ¿autofill failure, and gas loss/gain¿ but she was always able to restart and near the end of the call the pump was free of alarms.The iab is in the left axillary position, and we did discuss the non indicated insertion site.Advised her to drop the aug control several bars and after this the pump alarmed only once with ¿gas loss¿.With the axillary insertion, and no indication of blood, it is possible the catheter has a positional kink.Although the alarms have stopped, the physician is still planning to remove the iab and replace with another.There was no reported injury to the patient.

• 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 07004
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: dorota wolpiuk ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 10646272
• MDR Text Key: 219168915
• Report Number: 2248146-2020-00529
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2023
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000117747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 79