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

Model Number OCB4008BA

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

Patient Problems Death (1802); Vascular Dissection (3160)

Event Date 07/10/2017

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.Per the results of extensive bench testing, it has been determined that two positioning errors are required for the distal portion of the proximal balloon to significantly expand.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 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 dissection 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

The following information regarding the reported event was obtained from the hospital: following treatment of a ramus intermedius artery, the physician attempted to use the flash mini ostial system in the patient's rca.When inflating the proximal balloon, both ends of the balloon were noted as expanding (dog bone), resulting in a vessel dissection.The patient subsequently coded and expired.

• 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: 6787283
• MDR Text Key: 82460471
• Report Number: 3008700817-2017-00004
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: M917OCB4008BA0
• UDI-Public: M917OCB4008BA0
• 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: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: OCB4008BA
• Device Catalogue Number: OCB4008BA
• Device Lot Number: 160826-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2016
• 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: 73 YR