• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSTIAL CORPORATION FLASH OSTIAL SYSTEM OTW CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OSTIAL CORPORATION FLASH OSTIAL SYSTEM OTW CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number OTW6012BA
Device Problems Burst Container or Vessel (1074); Pressure Problem (3012)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/07/2018
Event Type  malfunction  
Event Description
The device did not work properly. It burst within the patient during first use and "never held any pressure".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFLASH OSTIAL SYSTEM OTW
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
OSTIAL CORPORATION
197 east hamilton ave
suite 101
campbell CA 95008
MDR Report Key7669277
MDR Text Key113418270
Report Number7669277
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/29/2018,06/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberOTW6012BA
Device Catalogue NumberOTW6012BA
Device Lot Number180308-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/29/2018
Event Location Hospital
Date Report to Manufacturer07/09/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-