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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUSTICK II; INTRODUCER, CATHETER
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BOSTON SCIENTIFIC CORPORATION ACCUSTICK II; INTRODUCER, CATHETER Back to Search Results
Model Number 35615
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Date 02/03/2020
Event Type  malfunction  
Event Description
It was reported that a tip fracture occurred.The target lesion was located in the liver.An accustick ii was selected for use in a percutaneous transhepatic biliary drainage (ptbd).During preparation, it was noted that the tip was broken.The procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that a tip fracture occurred.The target lesion was located in the liver.An accustick ii was selected for use in a percutaneous transhepatic biliary drainage (ptbd).During preparation, it was noted that the tip was broken.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual inspection revealed that only accustick device was returned for analysis (cannula, dilator, sheath, introducer needle and stylet.).No visual issues were observed with the introducer needle and stylet.The devices did not have any broken section.Residues were observed over the dilator indicating use and handling of the device.The distal section of the cannula, dilator and sheath had a severe kink.The tip of the dilator was damaged.A functional inspection revealed that the components could not be taken apart due to severe kinking at distal section.
 
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Brand Name
ACCUSTICK II
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9711278
MDR Text Key180124372
Report Number2134265-2020-01545
Device Sequence Number1
Product Code KGZ
UDI-Device Identifier08714729157625
UDI-Public08714729157625
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/11/2021
Device Model Number35615
Device Catalogue Number35615
Device Lot Number0021847582
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2020
Date Manufacturer Received03/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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