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U.S. Department of Health and Human Services

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

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OSTIAL CORPORATION FLASH MINI OSTIAL SYSTEM PTCA CATHETER Back to Search Results
Model Number OCB4008BA
Device Problems Deflation Problem (1149); Occlusion Within Device (1423); Compatibility Problem (2960); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/09/2017
Event Type  malfunction  
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 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.
 
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Brand NameFLASH MINI OSTIAL SYSTEM
Type of DevicePTCA CATHETER
Manufacturer (Section D)
OSTIAL CORPORATION
1221 innsbruck drive
sunnyvale CA 94089 1317
Manufacturer (Section G)
OSTIAL CORPORATION
1221 innsbruck drive
sunnyvale CA 94089 1317
Manufacturer Contact
jake wolenberg
1221 innsbruck drive
sunnyvale, CA 94089-1317
4085411006
MDR Report Key6324593
MDR Text Key67330348
Report Number3008700817-2017-00002
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131450
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 02/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Model NumberOCB4008BA
Device Catalogue NumberOCB4008BA
Device Lot Number160728-02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/10/2017 Patient Sequence Number: 1
Treatment
VISIPAQUE 320 OR OMNIPAQUE 300 CONTRAST
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