MAUDE Adverse Event Report: OSTIAL CORPORATION FLASH MINI OSTIAL SYSTEM; PTCA CATHETER

Model Number	OCB4008BA
Medical Device Problem Codes	Deflation Problem (1149); Occlusion Within Device (1423); Compatibility Problem (2960); Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The flash mini device used in the procedure was returned to ostial corporation for evaluation.A three (3) page summary of the evaluation has been attached.No issues were found with the performance of the returned device, though it was evident that the user had attempted to withdraw the inflated device into the guide catheter, resulting in the reported break in the catheter shaft.The inflation lumens on either side of the break were inspected and it was found that the proximal lumen was clogged by crystalized contrast and notably thicker contrast than expected (based on comparison to fresh contrast of the same nominal viscosity as the contrast used during the procedure).Following removal of the thick/crystalized contrast from the proximal lumen, there were no issues noted injecting or removing fresh contrast from the proximal balloon inflation lumen.While the thick/crystalized contrast is suspected to be the root cause of the reported problem, no definitive conclusions can be drawn as thickening/crystallization could have occurred following the procedure and issues with other accessory devices (e.G.Broken deflation syringe/indeflator) could also have led to this type of problem.In addition to the case details and device evaluation, ostial corporation reviewed the manufacturing documentation associated with the device lot used during the procedure.No issues were noted that would have contributed to the reported incident and all tensile strengths were found to be appropriate/well above the amount of force that is typically applied to the catheter.The instructions for use (ifu) for the product were also reviewed and it was verified that the ifu contains both appropriate instructions for using a 50/50 mixture of contrast/saline solution for inflation of the balloons and precautions/instructions for removing the device if excessive resistance is encountered when attempting to withdraw flash into the guide catheter.
Event or Problem Description
It was reported that one of the balloons on a 4.0x8mm flash mini device could not be deflated and that when attempting to withdraw the still inflated balloon into the guide catheter that the catheter shaft broke.The user was able to successfully remove both pieces of the flash mini device by retracting the device and guide catheter as a single unit.There was no patient injury associated with this procedure.

• Brand Name: FLASH MINI OSTIAL SYSTEM
• Common Device Name: PTCA CATHETER
• Manufacturer (Section D): OSTIAL CORPORATION; 1221 innsbruck drive; sunnyvale CA 94089 1317
• MDR Report Key: 6324593
• Report Number: 3008700817-2017-00002
• Device Sequence Number: 1007882
• Product Code: LOX
• UDI-Device Identifier: M917OCB4008BA0
• UDI-Public: M917OCB4008BA0
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K131450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2017

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: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: OCB4008BA
• Device Catalogue Number: OCB4008BA
• Device Lot Number: 160728-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2017
• Initial Report FDA Received Date: 02/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VISIPAQUE 320 OR OMNIPAQUE 300 CONTRAST
• Patient Age: 60 YR
• Patient Weight: 77