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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORBUSNEICH MEDICAL, INC. SAPPHIRE PTCA CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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ORBUSNEICH MEDICAL, INC. SAPPHIRE PTCA CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Lot Number 4258931808
Device Problems Fracture (1260); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2019
Event Type  malfunction  
Event Description
Performed coronary angioplasty without issue. Removed balloon from coronary and from sheath without incident, then attempted to remove balloon from wire. The balloon was stuck to wire and when attempted to remove the balloon, it fractured.
 
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Brand NameSAPPHIRE PTCA
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
ORBUSNEICH MEDICAL, INC.
5363 nw 35th ave
fort lauderdale FL 33309
MDR Report Key9426198
MDR Text Key169514234
Report Number9426198
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2019
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot Number4258931808
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/04/2019
Event Location Hospital
Date Report to Manufacturer12/06/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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