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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSTIAL CORPORATION FLASH OSTIAL SYSTEM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

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OSTIAL CORPORATION FLASH OSTIAL SYSTEM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER Back to Search Results
Model Number OCB5014BA
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Activation, Positioning or SeparationProblem (2906)
Patient Problem Vascular Dissection (3160)
Event Date 11/11/2020
Event Type  Injury  
Manufacturer Narrative
Based on the details of the case provided by the local sales representative and the hospital staff, there is no indication that the flash ostial system device did not perform as intended. The likely root cause for this incident was inflation of the balloon beyond the rated burst volume. In addition to the case details, ostial corporation reviewed the manufacturing documentation and lot release testing associated with the flash ostial system device lot that is suspected to have been used in this procedure. No issues were noted that would have contributed to the reported incident. The instructions for use for the flash ostial system were also reviewed and it was confirmed that vessel dissection is listed as a potential complication associated with the procedure and that the rated burst volume for the balloons are clearly listed.
 
Event Description
The patient was undergoing a tavr procedure and during the procedure it was determined that dilatation of a stent placed in the left main coronary artery was also required. Although not indicated, the physician elected to use the flash ostial system device to post dilate the stent. The outer balloon was inflated beyond the rated burst volume to expand the balloon to a larger diameter than intended per the product labeling. After exceeding the rated burst volume, the balloon ruptured, and an edge dissection was noted distal to the stent. A covered stent was placed to address the dissection and no further clinical sequelae were reported as a result of this event.
 
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Brand NameFLASH OSTIAL SYSTEM
Type of DevicePERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
Manufacturer (Section D)
OSTIAL CORPORATION
197 east hamilton ave
suite 101
campbell CA 95008
Manufacturer (Section G)
OSTIAL CORPORATION
197 east hamilton ave
suite 101
campbell CA 95008
Manufacturer Contact
jake wolenberg
197 east hamilton ave
suite 101
campbell, CA 95008
8443527411
MDR Report Key11267528
MDR Text Key230027513
Report Number3008700817-2021-00001
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122178
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2021
Device Model NumberOCB5014BA
Device Catalogue NumberOCB5014BA
Device Lot Number2143178
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2019
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: 02/02/2021 Patient Sequence Number: 1
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