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

Model Number	OCB4008BA
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ostial corporation has contacted the user facility; however, at this time no additional information regarding this case has been provided and the flash mini ostial system used was not available for return or evaluation.As such it could not be confirmed if there were any issues with the device used during the procedure.Based on the provided issue description, that the "balloon would not completely inflate during prep", it appears that use error may have contributed to this event the as per ifu the balloons are not supposed to be inflated during device preparation and are supposed to be left under vacuum or neutral pressure until they have been advanced to the target vessel in the patient.The manufacturing documentation and lot release testing for the flash mini device lot associated with this complaint was reviewed.No issues were noted that would have contributed to the reported issue of a balloon not inflating during prep.All devices passed the in-process leak checks and the lot release testing showed normal burst pressures and burst volumes.
Event or Problem Description
The user facility reported difficulty preparing the flash device.No additional details were provided.

• Brand Name: FLASH MINI 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
• Manufacturer (Section G): OSTIAL CORPORATION; 197 east hamilton ave; suite 101; campbell CA 95008
• Manufacturer Contact: janet shahbazi ; 197 east hamilton ave; suite 101; campbell, CA 95008 ; 8443527411
• MDR Report Key: 18823349
• Report Number: 3008700817-2024-00001
• Device Sequence Number: 7294160
• Product Code: LOX
• UDI-Device Identifier: M917OCB4008BA0
• UDI-Public: M917OCB4008BA0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: OCB4008BA
• Device Catalogue Number: OCB4008BA
• Device Lot Number: 82290945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 03/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown