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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSTIAL CORPORATION OSTIAL FLASH CATHETER PERICUTANEOUS

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OSTIAL CORPORATION OSTIAL FLASH CATHETER PERICUTANEOUS Back to Search Results
Model Number OCB4008BA
Device Problem Insufficient Information (3190)
Patient Problems Chest Pain (1776); Death (1802); Rupture (2208); Cardiac Tamponade (2226)
Event Date 07/10/2017
Event Type  Death  
Event Description
Rupture of rca post stenting with cardiac tamponade and subsequent death in cardiac cath lab. A 4 mm x 8 mm ostial flash balloon was used. On attempt to inflate balloon, the patient experienced sharp chest pain. Inflation was not completed. Acls protocol initiated. Cpr performed, pericardiocentesis performed x 3, patient expired.
 
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Brand NameOSTIAL FLASH
Type of DeviceCATHETER PERICUTANEOUS
Manufacturer (Section D)
OSTIAL CORPORATION
MDR Report Key6773106
MDR Text Key82138489
Report NumberMW5071407
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberOCB4008BA
Device Lot Number160826-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/04/2017 Patient Sequence Number: 1
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