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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 02/18/2019
Event Type  malfunction  
Event Description
It was reported that the radiopaque marker was not in the position.An accustick ll catheter was selected for use for a percutaneous transhepatic biliary drainage procedure.During preparation, it was found out that the radiopaque marker was marked only in the proximal portion of the catheter, when it is normally marked on the distal section.The procedure was completed with another of the same device.No complications reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.One accustick device was returned for analysis (cannula, dilator, sheath, introducer needle and stylet.).No visual damages were observed with the cannula, dilator, introducer needle and stylet.Residues in the distal section of the dilator indicates use and handling of the device.The tip of the sheath is damaged and the ro marker has been pushed proximally approximately 3.5 cm toward the hub.Marker impression on the sheath surface indicates the ro marker had been properly assembled and swaged onto the distal end.
 
Event Description
It was reported that the radiopaque marker was not in the position.An accustick ll catheter was selected for use for a percutaneous transhepatic biliary drainage procedure.During preparation, it was found out that the radiopaque marker was marked only in the proximal portion of the catheter, when it is normally marked on the distal section.The procedure was completed with another of the same device.No complications reported.
 
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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 Key8413218
MDR Text Key138560681
Report Number2134265-2019-02355
Device Sequence Number1
Product Code KGZ
UDI-Device Identifier08714729157625
UDI-Public08714729157625
Combination Product (y/n)N
PMA/PMN Number
K952828
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/06/2021
Device Model Number35615
Device Catalogue Number35615
Device Lot Number22902800
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2019
Initial Date Manufacturer Received 02/18/2019
Initial Date FDA Received03/12/2019
Supplement Dates Manufacturer Received03/21/2019
Supplement Dates FDA Received04/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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