FDA Adverse Event Death Summary report: N

BALLOON CATHETER

MDR report key: 11655223 · Received April 12, 2021

Report

Report Number
MW5100710
Event Type
Death
Date Received
April 12, 2021
Date of Event
March 19, 2021
Report Date
April 8, 2021
Manufacturer
ARROW / ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORAT
Product Code
DSP
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PT RECEIVED A CABG BY DR AT (B)(6) 2021. HE HAD TO BE PLACED ON TO BYPASS TWICE DURING THE SURGERY AND WAS BROUGHT OUT TO THE CTICU WITH A BALLOON PUMP (IABP) AT 1400. AT 2245, THE IABP BEGAN ALARMING HELIUM LOSS. THE IABP ENGINEER AND CT SURGERY ON CALL WERE AT THE BEDSIDE AT 2249. THE BALLOON WAS PULLED OUT OF THE PATIENT AT 2300 BY DR AFTER DISCOVERING THAT THE BALLOON HAD RUPTURED. DR WAS NOTIFIED. AT 0000 ON (B)(6) 2021, IT WAS DISCOVERED THAT THE PATIENT'S PUPILS WERE SLUGGISH AND PATIENT WAS NOT RESPONDING TO DEEP DISTAL STIMULATION. DR WAS AWARE. PATIENT WENT FOR MULTIPLE CT SCANS AT 0125 AND 0540. NEUROLOGY WAS CONSULTED AFTER THE FIRST SCAN WAS CONCERNING FOR AIR EMBOLI, THROMBUS, AND STROKE. AT 0851 THE PATIENT'S PUPILS WERE NONREACTIVE. THE PATIENT'S FAMILY WAS CALLED IN AND THE PATIENT WAS MADE CMO. FDA SAFETY REPORT ID#: (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
551562 BALLOON CATHETER SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP ARROW / ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORAT

Patients

Seq Age Sex Outcome Treatment
1 69 YR Death