MAUDE Adverse Event Report: OSTIAL CORPORATION FLASH OSTIAL SYSTEM OTW; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number OTW6012BA

Device Problems Burst Container or Vessel (1074); Pressure Problem (3012)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/07/2018

Event Type  malfunction  

Event Description

The device did not work properly.It burst within the patient during first use and "never held any pressure".

• Brand Name: FLASH OSTIAL SYSTEM OTW
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): OSTIAL CORPORATION; 197 east hamilton ave; suite 101; campbell CA 95008
• MDR Report Key: 7669277
• MDR Text Key: 113418270
• Report Number: 7669277
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2018,06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OTW6012BA
• Device Catalogue Number: OTW6012BA
• Device Lot Number: 180308-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32485 DA
• Patient Weight: 75