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

Model Number	OCB4008BA
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906); Device Handling Problem (3265)
Health Effect - Clinical Codes	Death (1802); Vascular Dissection (3160)
Date of Event	07/10/2017
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: PTCA CATHETER
• Manufacturer (Section D): OSTIAL CORPORATION; 1221 innsbruck drive; sunnyvale CA 94089 1317
• MDR Report Key: 6787283
• Report Number: 3008700817-2017-00004
• Device Sequence Number: 16497044
• Product Code: LOX
• UDI-Device Identifier: M917OCB4008BA0
• UDI-Public: M917OCB4008BA0
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K131450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Age: 73 YR