MAUDE Adverse Event Report: OSTIAL CORPORATION FLASH MINI OSTIAL SYSTEM; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number OCB4508BA

Device Problems Burst Container or Vessel (1074); Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919); Air/Gas in Device (4062)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

During the cardiac catheterization with selective coronary angiography, an ostial dual ptca (percutaneous transluminal coronary angioplasy) balloon was used during coronary intervention (it is unknown at this time which coronary artery was accessed by the device, possibly the rca [right coronary artery]).The proximal balloon on the ostial device burst.This was followed by the operating interventional cardiologist to visualize what he believed to be an air embolism travel down the coronary artery.There were no clinical changes observed at this time.According to the investigation, the device ifu calls for use of supplied syringe only.The physician chose to use a standard manifold syringe for injection, which is suspected to inadvertently caused the balloon to burst.The syringe was filled with the recommended contrast/saline media, however the physician stated that he observed an air bolus during the coronary angiogram.This did not cause any adverse outcomes and required only initial monitoring to preclude harm.Physician requested that device be sequestered and sent to the manufacturer for product evaluation.The device has been returned to the ostial corp territory manager.

• Brand Name: FLASH MINI OSTIAL SYSTEM
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): OSTIAL CORPORATION; 197 e. hamilton ave. suite 101; campbell CA 95008
• MDR Report Key: 16003712
• MDR Text Key: 305701767
• Report Number: 16003712
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/08/2022

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
• Device Operator: Health Professional
• Device Model Number: OCB4508BA
• Device Catalogue Number: OCB4508BA
• Device Lot Number: 82209621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White