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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERILMED, INC.; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
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STERILMED, INC.; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER Back to Search Results
Model Number ACU10135936
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiac Perforation (2513)
Event Date 03/01/2016
Event Type  Injury  
Manufacturer Narrative
It was reported that the device will not be returned to the manufacturer.No device history report was reviewed as no lot number was given.
 
Event Description
It was reported that reported that a cardiac perforation was noticed after the physician was not able to use the c3 mapping module.No medical intervention was provided.It was reported that patient was in stable condition.The actual device is reported as not being returned to the manufacturer.
 
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Type of Device
REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
Manufacturer (Section D)
STERILMED, INC.
11400 73rd ave n
maple grove MN
Manufacturer Contact
jason anderson
5010 cheshire parkway
suite 2
plymouth, MN 55446
7634888348
MDR Report Key5566841
MDR Text Key42333832
Report Number2134070-2016-00020
Device Sequence Number1
Product Code OWQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043453
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial
Report Date 03/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberACU10135936
Device Catalogue NumberACU10135936
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SMRTTCH:(B)(4), SMRTABLTE GEN (B)(4)
Patient Outcome(s) Other;
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