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

Catalog Number 0684-00-0575

Device Problems Fracture (1260); Device Contamination with Body Fluid (2317); Device Operates Differently Than Expected (2913)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/22/2017

Event Type  Injury  

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.(b)(4).

Event Description

It was reported that on (b)(6) 2017 about 3.00 clock during intra-aortic balloon (iab) therapy, the iab became full of blood.The pressure gauge in the catheter was not functioning.In the removal of the catheter, the fractured remained in the femoral artery, which necessitated surgery.The catheter was removed.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• 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: 7039316
• MDR Text Key: 92293876
• Report Number: 2248146-2017-00644
• Device Sequence Number: 1
• Product Code: DSP
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/23/2020
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000047920
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 10/23/2017
• Date Device Manufactured: 03/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention