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U.S. Department of Health and Human Services

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

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ORBUSNEICH MEDICAL TRADING, INC. SAPPHIRE II PRO CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 210-153-5UU
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)
Event Date 04/28/2021
Event Type  Injury  
Event Description
Perforation of lva after stent placement, balloon inserted for perforation. Tip of balloon broke off still located in the lva. Fda safety report id# (b)(4).
 
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Brand NameSAPPHIRE II PRO
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
ORBUSNEICH MEDICAL TRADING, INC.
MDR Report Key11760107
MDR Text Key248798167
Report NumberMW5101105
Device Sequence Number1
Product Code LOX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/03/2022
Device Model Number210-153-5UU
Device Lot Number4203582002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/30/2021 Patient Sequence Number: 1
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