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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRA ICE PLUS TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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BOSTON SCIENTIFIC CORPORATION ULTRA ICE PLUS TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number M00499120
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/09/2020
Event Type  malfunction  
Event Description
Incident description: catheter was inserted into patient, was not working properly. Removed and a crack in catheter lining was noted. Subsequently, another boston scientific 8. 5f 110cm cath ultra ice plus echo was used. The procedure was completed without complications.
 
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Brand NameULTRA ICE PLUS
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10095874
MDR Text Key192385408
Report Number10095874
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00499120
Device Lot Number24887480
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/21/2020
Event Location Hospital
Date Report to Manufacturer05/28/2020
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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