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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRA ICE PLUS; CATHETER, ULTRASOUND, INTRACARDIAC
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BOSTON SCIENTIFIC CORPORATION ULTRA ICE PLUS; CATHETER, ULTRASOUND, INTRACARDIAC Back to Search Results
Model Number 86200
Device Problems Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944); Improper Flow or Infusion (2954)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/16/2019
Event Type  malfunction  
Event Description
It was reported that foreign material present in the tip of the device.During preparation of the ultra ice plus catheter for insertion into the patient, it was not possible to flush the catheter.A foreign object was discovered in the distal tip.The catheter was replaced and the procedure was performed without issue.
 
Manufacturer Narrative
Correction: note additional device code of improper flow or infusion.Analysis of returned product revealed that there were residues inside the imaging window which confirmed the reported "foreign object was found".No visible damage to the catheter was noted.The device was also functionally tested and it performed as intended (device was able to flush); consequently, not confirming the reported "it could not flush".Although the device was able to be flushed during testing, according to the event description the issue occurred during insertion; this, along with the residues found on the device, leads to the belief that the "clogging" most likely occurred due to procedural factors coming in contact with the device and, in turn, decreasing its functional and physical capabilities.The investigation conclusion is adverse event related to procedure.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
It was reported that foreign material present in the tip of the device.During preparation of the ultra ice plus catheter for insertion into the patient, it was not possible to flush the catheter.A foreign object was discovered in the distal tip.The catheter was replaced and the procedure was performed without issue.
 
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Brand Name
ULTRA ICE PLUS
Type of Device
CATHETER, ULTRASOUND, INTRACARDIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key8608202
MDR Text Key144982399
Report Number2134265-2019-05232
Device Sequence Number1
Product Code ITX
UDI-Device Identifier08714729904380
UDI-Public08714729904380
Combination Product (y/n)N
PMA/PMN Number
K160173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 07/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/08/2021
Device Model Number86200
Device Catalogue Number86200
Device Lot Number0023160352
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2019
Date Manufacturer Received06/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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