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

Model Number OCB4008BA

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2023

Event Type  malfunction  

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 Description

The user facility reported difficulty preparing the flash device.No additional details were provided.

• Brand Name: FLASH MINI OSTIAL SYSTEM
• Type of Device: 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
• MDR Text Key: 337739316
• Report Number: 3008700817-2024-00001
• 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: K152485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2023
• 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