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U.S. Department of Health and Human Services

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

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OSTIAL CORPORATION FLASH CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number OCB5014BA
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Death (1802); Rupture (2208)
Event Date 02/01/2017
Event Type  Death  
Event Description
Physician reported the balloon had opened in the opposite direction, thereby causing a rupture of the left anterior descending (lad) vessel. The pt expired within 24 hours post procedure.
 
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Brand NameFLASH
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
OSTIAL CORPORATION
1221 innsbruck dr.
sunnyvale CA 94089
MDR Report Key6328620
MDR Text Key67347597
Report Number6328620
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 02/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Model NumberOCB5014BA
Device Lot Number160627-03
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/03/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer02/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/14/2017 Patient Sequence Number: 1
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