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

Model Number	OTW6012BA
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
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 ostial system otw (flash otw) device used during the case has not been returned.As such it could not be confirmed if there were any issues with device used during the procedure.The manufacturing documentation and lot release testing for the lot of flash otw devices associated with this complaint was reviewed.No issues were noted that would have contributed to the reported issue of one of the balloons not holding pressure.All devices passed the in-process leak checks and the lot release testing showed normal burst pressures and burst volumes.Corrected data: of the user facility report indicated that the device in question was available for evaluation.The user facility has not confirmed to ostial corporation whether this device is available or can be returned.Of the user facility report was accidentally filled out instead.The user facility did provide a copy of the report to the fda but did not provide a copy of the report to ostial corporation.
Event or Problem Description
The fda forwarded ostial corporation an mdr from a user facility indicating that one of the balloons for a flash ostial system otw device may have been damaged during use and "never held any pressure".There were no patient injuries reported in association with this event.At this time, the user facility has been unable to provide ostial corporation with any additional feedback regarding the reported event and has not indicated if the device used in this case is available for evaluation.Additional details from the user facility mdr report are provided below: intended procedure: five vessel fenestrated/branched- evar with pmeg zfen- p- 2- 26- 124-r including distal bifurcate zfen- d- 12 - 28- 91-c and stented fenestrations to the celiac, sma, right renal artery, left main renal artery, and stented branch to the left lower pole renal artery.Percutaneous access of bilateral common femoral arteries with preclosure of 20 fr sheath on the right and 14 fr sheath on the left.

• Brand Name: FLASH OSTIAL SYSTEM OTW
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): OSTIAL CORPORATION; 197 east hamilton ave; suite 101; campbell CA 95008
• MDR Report Key: 7795812
• Report Number: 3008700817-2018-00001
• Device Sequence Number: 2434246
• Product Code: LIT
• UDI-Device Identifier: M917OTW6012BA0
• UDI-Public: M917OTW6012BA0
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K150946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2018

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: 09/30/2019
• Device Model Number: OTW6012BA
• Device Catalogue Number: OTW6012BA
• Device Lot Number: 180308-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Weight: 75