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

Catalog Number 0684-00-0575

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Hemorrhage/Bleeding (1888); Weakness (2145); Loss of consciousness (2418)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 during intra-aortic balloon (iab) therapy there was frank blood noted in gas line and the patient became unresponsive.When the patient woke up there was weakness on one side.It was noted the patient had to undergo an embolectomy, but regained movement of all extremities.A new iab was inserted via the "axiallary" approach, which is an off-label use.The serious injury was not attributed to the device by the facility.

Manufacturer Narrative

Incorrect device returned by customer.Customer is not returning the catheter.(b)(4).[from] the product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.[to] 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 during intra-aortic balloon (iab) therapy there was frank blood noted in gas line and the patient became unresponsive.When the patient woke up there was weakness on one side.It was noted the patient had to undergo an embolectomy, but regained movement of all extremities.A new iab was inserted via the axiallary approach, which is an off-label use.The serious injury was not attributed to the device by the facility.

Manufacturer Narrative

The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint #(b)(4); record id (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy there was frank blood noted in gas line and the patient became unresponsive.When the patient woke up there was weakness on one side.It was noted the patient had to undergo an embolectomy, but regained movement of all extremities.A new iab was inserted via the axiallary approach, which is an off-label use.The serious injury was not attributed to the device by the facility.

• 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
• MDR Report Key: 8152023
• MDR Text Key: 129969113
• Report Number: 2248146-2018-00709
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/14/2018
• Device Age: YR
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 29 YR