MAUDE Adverse Event Report: OSTIAL CORPORATION FLASH MINI OSTIAL SYSTEM; PTCA CATHETER

Model Number OCB3508BA

Device Problems Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906); Device Handling Problem (3265)

Patient Problems Death (1802); Perforation of Vessels (2135); Aortic Dissection (2491)

Event Date 09/11/2015

Event Type  Death  

Manufacturer Narrative

The hospital is currently conducting their own investigation into the reported incident and has not made the device or cine files from the case available for review.It has been requested that the hospital return the device along with complete cines from the case following completion of their investigation; however, no timetable has been provided by the hospital as to when the investigation is expected to be completed.While the device from the case hasn't been returned for evaluation, one of the physicians at the hospital was able to provide some case details and a description of the event.Additionally, ostial corporation was able to obtain one still image from the case showing the inflated flash mini device.Based on still image from the case, it is clear that the proximal balloon of the flash mini device had been overinflated to between 1.5 to 2 times the maximum recommended inflation volume of 0.4cc.It was also noted that the distal portion of the balloon seemed to extend well past the distal edge of the stent being treated with almost the entire working length of the balloon likely outside of the stent.Placing the device too far distally within the target vessel/stent can result in the proximal portion of balloon being excessively constrained and can force the inflation volume that would typically fill the proximal portion of the balloon to the distal portion.Bench testing of equivalent product confirmed that the shape of the balloons seen in the provided image could only be achieved if the distal portion of the device was placed well outside of the stent and then the balloons were overinflated.Per the device ifu, the distal portion of the device should not extend past the distal edge of the stent and the balloon should not be inflated past the maximum recommended inflation volume.Based on the available case details, there is no indication that the flash mini device did not perform as intended.The most likely potential causes identified for the vessel damage and subsequent patient death are incorrect positioning of the device and inflation beyond the maximum recommended inflation volume.In addition to the case details, a review of the manufacturing documentation associated with the device lot was performed and no issues were noted that would have contributed to the reported event.The instructions for use for the product were also reviewed and it was verified that dissection and death are listed as a potential complications associated with the procedure.

Event Description

A stemi patient was being treated for a total rca occlusion at the mid portion of the vessel via balloon angioplasty and placement of a 2.5x12mm stent (unknown make).An additional 3.5x8mm abbott xience stent was placed at the ostium of the vessel and a 3.5x8mm flash mini ostial system device was attempted to be used to post dilate this stent (it is not known at this time why this stent was placed at the ostium).When the proximal balloon of the flash mini device was inflated, the distal portion of the balloon significantly expanded, similar to how the proximal portion is intended to expand, as opposed to only the proximal portion significantly expanding (as intended).An aortic dissection occurred and the patient subsequently passed away.

• Brand Name: FLASH MINI OSTIAL SYSTEM
• Type of Device: PTCA 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 Key: 5139476
• MDR Text Key: 27896775
• Report Number: 3008700817-2015-00005
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2016
• Device Model Number: OCB3508BA
• Device Catalogue Number: OCB3508BA
• Device Lot Number: 030615-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 80 YR