MAUDE Adverse Event Report: OSTIAL CORPORATION FLASH OSTIAL SYSTEM; PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Model Number	OCB5014BA
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the details of the case provided by the local sales representative and the hospital staff, there is no indication that the flash ostial system device did not perform as intended.The likely root cause for this incident was inflation of the balloon beyond the rated burst volume.In addition to the case details, ostial corporation reviewed the manufacturing documentation and lot release testing associated with the flash ostial system device lot that is suspected to have been used in this procedure.No issues were noted that would have contributed to the reported incident.The instructions for use for the flash ostial system were also reviewed and it was confirmed that vessel dissection is listed as a potential complication associated with the procedure and that the rated burst volume for the balloons are clearly listed.
Event or Problem Description
The patient was undergoing a tavr procedure and during the procedure it was determined that dilatation of a stent placed in the left main coronary artery was also required.Although not indicated, the physician elected to use the flash ostial system device to post dilate the stent.The outer balloon was inflated beyond the rated burst volume to expand the balloon to a larger diameter than intended per the product labeling.After exceeding the rated burst volume, the balloon ruptured, and an edge dissection was noted distal to the stent.A covered stent was placed to address the dissection and no further clinical sequelae were reported as a result of this event.

• Brand Name: FLASH OSTIAL SYSTEM
• Common Device Name: PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
• Manufacturer (Section D): OSTIAL CORPORATION; 197 east hamilton ave; suite 101; campbell CA 95008
• MDR Report Key: 11267528
• Report Number: 3008700817-2021-00001
• Device Sequence Number: 2590323
• Product Code: LOX
• UDI-Device Identifier: M917OCB5014BA0
• UDI-Public: M917OCB5014BA0
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K122178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2021

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: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: OCB5014BA
• Device Catalogue Number: OCB5014BA
• Device Lot Number: 2143178
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 02/02/2021
• 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: Life Threatening; Required Intervention