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

Model Number	OCB4508BA
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event description was provided to ostial via email by their sales representative, along with user facility report mdr # (b)(4) from the fda.The description stated that during a complex intervention, attempts were made to advance an ostial flash balloon into the coronary artery for angioplasty.The balloon would not advance all the way through the guide and had to be removed.The flash device was promptly removed from service, and there was no harm to the patient.The user facility report mdr # (b)(4) indicated a malfunction of devices.The device was returned to the manufacturer for product evaluation.
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 flash mini device used in the procedure was returned to the ostial corporation for evaluation.As part of bench testing, the complaint device and a 0.014" guide wire were advanced through a similar 6f guide catheter (medtronic) with no difficulty through the entire guide catheter under neural pressure.Additionally, as part of bench testing, the inner and outer balloons of the complaint device were inflated after exiting the 6f guide catheter to their nominal inflation volume/pressure and inspected for leaks/damage with no issues found.It was observed that catheter shaft was kinked near the hub (within ~30cm), which may have been due to excessive force applied during the unsuccessful passing of the flash.The likely root causes for this complaint are related to patient anatomy and potentially inadequate support from accessory devices (guide catheter and guidewire).In addition, 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.Additionally, the flash device was not used and removed without incident from the patient.
Additional Manufacturer Narrative
This is the first follow-up report to the initial report # 3008700817-2025-00002.The related medical device report (mdr) report number (b)(4) was included in block h10, related report number field.

• Brand Name: FLASH MINI OSTIAL SYSTEM
• Common Device Name: PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
• Manufacturer (Section D): OSTIAL CORPORATION; 747 camden ave.; suite a; campbell CA 95008
• Manufacturer (Section G): OSTIAL CORPORATION; 747 camden ave.; suite a; campbell CA 95008
• Manufacturer Contact: janet shahbazi ; 747 camden ave.; suite a; campbell, CA 95008 ; 8443527411
• MDR Report Key: 21710485
• Report Number: 3008700817-2025-00002
• Device Sequence Number: 20004109
• Product Code: LOX
• UDI-Device Identifier: M917OCB4508BA0
• UDI-Public: M917OCB4508BA0
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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 Model Number: OCB4508BA
• Device Catalogue Number: OCB4508BA
• Device Lot Number: 82305995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANGIOPLASTY CATHETER02.; GUIDE CATHETER.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male