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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRA ICE PLUS - PI CATHETER, ULTRASOUND, INTRAVASCULAR

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BOSTON SCIENTIFIC CORPORATION ULTRA ICE PLUS - PI CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Model Number 1816-06
Device Problem Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2021
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled. An ultra ice vascular imaging catheter was selected for use in the iliac vein. The catheter was prepped and inserted through the sheath. However, no image appeared on the screen. The catheter was removed and re-flushed but there still was no image. The procedure was cancelled and rescheduled for a later date. The patient experienced no complications.
 
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Brand NameULTRA ICE PLUS - PI
Type of DeviceCATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11544494
MDR Text Key241562327
Report Number2134265-2021-03611
Device Sequence Number1
Product Code DXK
UDI-Device Identifier08714729982500
UDI-Public08714729982500
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1816-06
Device Catalogue Number1816-06
Device Lot Number0026475575
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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