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

Model Number OCB3008BA

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)

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.

• 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: 5387151
• MDR Text Key: 36704137
• Report Number: 3008700817-2016-00001
• 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
• 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 Received: 01/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2017
• Device Model Number: OCB3008BA
• Device Catalogue Number: OCB3008BA
• Device Lot Number: 150921-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2015
• 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: 76 YR
• Patient Weight: 96