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

Catalog Number 0684-00-0575

Device Problems Difficult or Delayed Positioning (1157); Activation, Positioning or Separation Problem (2906)

Patient Problem Death (1802)

Event Date 10/19/2016

Event Type  Death  

Manufacturer Narrative

It is confirmed that the device will not be returning to the manufacturer, we are unable to complete an evaluation on the affected product.If additional information or follow up is provided, we will send a supplemental report with additional findings.(b)(4).The iab was not returned and so could not be evaluated for the reported event.Since the device information was not available, the customer shipping history was reviewed to determine the most likely lot(s) involved in this event.(b)(4).

Event Description

During insertion, iab unraveled and made it extremely difficult to get in.Iab was left in t-handle until very end.All technique suggestions appeared to be followed, though md may have turned iab a bit during insertion.About 1/2 way thru sheath, the md could not advance iab any further.He went to a competitor's 8 french sheath on the other leg and attempted to insert there without any luck.When going back to the original insertion site with our sheath, the tech wet the catheter a bit and turned the catheter to "reward" it and they were able to get it in.Technician knew that steps he was taking at end were against our recommendations.However this was a stemi and the patient was very ill- they needed to get support to the patient.

• 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: 6104452
• MDR Text Key: 59967222
• Report Number: 2248146-2016-00090
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2016

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?: No
• Device Operator: No Information
• Device Expiration Date: 08/28/2018
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000015075
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2016
• Initial Date FDA Received: 11/15/2016
• Date Device Manufactured: 08/28/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death