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

Catalog Number 0684-00-0575

Device Problems Occlusion Within Device (1423); Pumping Stopped (1503); Device Displays Incorrect Message (2591)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) 2015 02:47 pm (gmt-4:00) added by (b)(4)): since the device is not available to be returned to maquet cardiovascular, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Internal complaint number: (b)(4).

Event Description

Blood detected in helium tubing.Gas loss alarm: physician ordered to continue balloon pump.Patient needed to stay anti-coagulated and could not replace balloon.Patient coded when balloon pumped stopped because the helium line clotted off.Physician left balloon in place: very anti-coag.

Manufacturer Narrative

Dates were not entered in the initial mdr.Date of this report: 09/01/2015; manufacturer date: 09/01/2015.

Event Description

Blood detected in helim tubing.Gas loss alarm: physician ordered to continue balloon pump.Patient needed to stay anti-coagulated and could not replace balloon.Patient coded when balloon pumped stoped because the helium line clotted off.Physician left balloon in place: very anti-coag.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB CATHETER
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 5110715
• MDR Text Key: 27026691
• Report Number: 2248146-2015-01021
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 01/30/2018

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: No Information
• Device Expiration Date: 06/24/2018
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000012008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Supplement Dates Manufacturer Received: 09/01/2015
• Supplement Dates FDA Received: 01/31/2018
• Date Device Manufactured: 06/24/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening