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Model Number OCB5014BA
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 02/01/2017
Event Type  Death  
Manufacturer Narrative
The flash device used in the procedure was not returned to ostial corporation for evaluation and the hospital has indicated that they will not be returning the device for evaluation. Based on a review of the provided case details, bench testing to recreate the reported issue and a review of the manufacturing records associated with the device lot used during this case, it is unlikely that there were any issues with the performance of the flash device. The unintended expansion of the distal portion of the balloon was likely due incorrect positioning of the device prior to inflation. Per the results of the bench testing, two positioning errors are required for the distal portion of the proximal balloon to significantly expand and appear to inflate in the opposite direction. The distal portion of the proximal balloon must extend well past the distal edge of a stent being treated and the majority of the working length of the proximal balloon needs to be constrained within the target vessel/stent. These positioning errors 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 bench testing conducted to recreate the reported event, 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. Device not returned to manufacturer.
Event Description
The hospital course for this case was provided and indicated the following: (b)(6) year old with history of coronary artery disease, cabg in (b)(6) 2010 (lima to lad that fills diags and lcx in retrograde, cvg to diag and svg to lcx) with bio prosthetic mvr, afib on eliquis, (b)(6), and class iii angina who presented for high risk cardiac catheterization for intervention to her cto of the lm. Today, her pci was complicated by rupture of the left main coronary artery with resulting hemopericardium. Two stents were placed in the lm into the lad across the lcx. This resulted in the lateral wall infarct and cardiogenic shock. An impella was already placed given the high risk nature of this pci. While in the cath lab, the patient suffered cardiopulmonary arrest, requiring an unknown amount of cpr and epinephrine. This procedure was further complicated by a type a aortic dissection extending to the proximal right brachycephalic artery. The patient arrived to the cicu intubated and sedated on precedex. She was actively receiving drip running at 5 mcg. Patient became bradycardic despite increasing pressors requirements and was rushed back to the cath lab. A tvp was placed. The impella was repositioned, but her prognosis remained poor. The physician indicated to the hospital's product safety clinical coordinator that the coronary artery rupture occured in the lad following the use of a 5. 0x12mm flash ostial system device and that the flash balloon appeared to expand in the opposite direction (e. G. The distal portion of the balloon expanded to an excessive diameter).
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Manufacturer (Section D)
1221 innsbruck drive
sunnyvale CA 94089 1317
Manufacturer (Section G)
1221 innsbruck drive
sunnyvale CA 94089 1317
Manufacturer Contact
jake wolenberg
1221 innsbruck drive
sunnyvale, CA 94089-1317
MDR Report Key6394007
MDR Text Key69560794
Report Number3008700817-2017-00003
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
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 03/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2018
Device Model NumberOCB5014BA
Device Catalogue NumberOCB5014BA
Device Lot Number160627-03
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2016
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: 03/09/2017 Patient Sequence Number: 1