• 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 MINI OSTIAL SYSTEM PTCA CATHETER

  • 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 MINI OSTIAL SYSTEM PTCA CATHETER Back to Search Results
Model Number OCB3008BA
Device Problems Improper or Incorrect Procedure or Method (2017); Activation, Positioning or SeparationProblem (2906); Device Handling Problem (3265)
Patient Problems Death (1802); Perforation of Vessels (2135)
Event Date 12/17/2015
Event Type  Death  
Manufacturer Narrative
The flash mini device used in the procedure was returned to ostial corporation for evaluation. A two (2) page summary of the evaluation has been attached. No issues were found with the performance of the returned device, though the distal portion of the proximal balloon had clearly been deformed by overexpansion during use. Per the results of the evaluation, it was found that the root cause of the incident was grossly incorrect positioning of the device prior to inflation. In addition to returning the device, the hospital provided a complete set of cine angiograms taken throughout the case. Evaluation of the cines showing the inflation of the flash mini device confirmed that the device had been inflated while incorrectly positioned with the distal portion of the proximal balloon extending well past the distal edge of the stent being treated and with the entire working length of the proximal balloon inside of the target vessel. Placing the device too far distally within the target vessel/stent can result in the proximal portion of the balloon being excessively constrained and can force the inflation volume that would typically fill the proximal portion of the balloon into the distal portion. Per the device ifu, the distal portion of the proximal balloon should not extend past the distal edge of the stent and the proximal portion of the balloon should not be inflated inside of the target vessel. In addition to the case details, ostial corporation reviewed the manufacturing documentation associated with the device lot used during the procedure. No issues were noted that would have contributed to the reported incident. The instructions for use for the product were also reviewed and it was verified that vessel perforation is listed as a potential complication associated with the procedure and that the user is clearly instructed on how the device should be positioned during use.
 
Event Description
A 3. 0x18mm alpine stent was deployed in the patient's rca. The physician attempted to post dilate the stent using a 3. 0x8mm flash mini ostial system device. The distal balloon inflated as expected; however, when the physician attempted to inflate the proximal balloon, it significantly expanded on the distal side of the stent as opposed to expanding on the proximal side of the stent (as expected). The patient experienced excruciating chest pain and the device was removed. Subsequent angiograms showed a large perforation. There were multiple attempts to repair the perforation that were unsuccessful and the patient passed away.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFLASH MINI OSTIAL SYSTEM
Type of DevicePTCA CATHETER
Manufacturer (Section D)
OSTIAL CORPORATION
1221 innsbruck drive
sunnyvale CA 94089 1317
Manufacturer (Section G)
OSTIAL CORPORATION
1221 innsbruck drive
sunnyvale CA 94089 1317
Manufacturer Contact
jake wolenberg
1221 innsbruck drive
sunnyvale, CA 94089-1317
4085411006
MDR Report Key5387151
MDR Text Key36704137
Report Number3008700817-2016-00001
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131450
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 01/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2017
Device Model NumberOCB3008BA
Device Catalogue NumberOCB3008BA
Device Lot Number150921-02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/22/2016 Patient Sequence Number: 1
-
-